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: 2026-08-18
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 international scale (IS) as measured by RQ-PCR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
233 participants
Primary outcome timeframe
24 weeks
Results posted on
2026-08-18
Participant Flow
Participants were treated at a total of 84 sites.
Randomization was stratified by major cytogenetic response (MCyR) at screening.
Participant milestones
| Measure |
Bosutinib
Participants randomized to bosutinib 500mg QD
|
Asciminib
Participants randomized to asciminib 40mg BID
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
157
|
|
Overall Study
Treated
|
76
|
156
|
|
Overall Study
Not Treated
|
0
|
1
|
|
Overall Study
Switched to Receive Asciminib
|
25
|
0
|
|
Overall Study
COMPLETED
|
8
|
77
|
|
Overall Study
NOT COMPLETED
|
68
|
80
|
Reasons for withdrawal
| Measure |
Bosutinib
Participants randomized to bosutinib 500mg QD
|
Asciminib
Participants randomized to asciminib 40mg BID
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
28
|
40
|
|
Overall Study
Physician Decision
|
7
|
13
|
|
Overall Study
Adverse Event
|
21
|
11
|
|
Overall Study
Subject/Guardian Decision
|
7
|
6
|
|
Overall Study
Death
|
0
|
4
|
|
Overall Study
Progressive Disease
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Not treated
|
0
|
1
|
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
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=76 Participants
Participants randomized to bosutinib 500mg QD
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 13.49 • n=298 Participants
|
51.0 years
STANDARD_DEVIATION 13.95 • n=102 Participants
|
51.0 years
STANDARD_DEVIATION 13.61 • n=400 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=298 Participants
|
45 Participants
n=102 Participants
|
120 Participants
n=400 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=298 Participants
|
31 Participants
n=102 Participants
|
113 Participants
n=400 Participants
|
|
Race/Ethnicity, Customized
White
|
118 participants
n=298 Participants
|
56 participants
n=102 Participants
|
174 participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 participants
n=298 Participants
|
11 participants
n=102 Participants
|
33 participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 participants
n=298 Participants
|
2 participants
n=102 Participants
|
10 participants
n=400 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=298 Participants
|
0 participants
n=102 Participants
|
1 participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=298 Participants
|
7 participants
n=102 Participants
|
12 participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 participants
n=298 Participants
|
0 participants
n=102 Participants
|
3 participants
n=400 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set (FAS): The FAS comprised of all randomized participants.
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 international scale (IS) as measured by RQ-PCR.
Outcome measures
| Measure |
Asciminib
n=157 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=76 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Major Molecular Response (MMR) Rate at 24 Weeks
|
25.48 Percentage of participants
|
13.16 Percentage of participants
|
SECONDARY outcome
Timeframe: 96 WeeksPopulation: Full Analysis Set (FAS): The FAS comprised of all randomized participants.
MMR at 96 weeks was defined as the percentage of participants with MMR at 96 weeks. 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 international scale (IS) as measured by RQ-PCR.
Outcome measures
| Measure |
Asciminib
n=157 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=76 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Major Molecular Response (MMR) Rate at 96 Weeks (Key Secondary Endpoint)
|
37.58 Percentage of participants
|
15.79 Percentage of participants
|
SECONDARY outcome
Timeframe: at 24, 48, 72, 96, 120 and 144 weeksPopulation: CCyR analysis set is a subset of FAS and included participants who were not in CCyR at baseline. FAS comprised of all randomized participants.
Cytogenic response included Complete, Partial, Major, Minor, Minimal and no response. Cytogenetic response was assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases; Partial (PCyR) - \>0 to 35% Ph+ metaphases; Major (MCyR) - 0 to 35% Ph+ metaphases; Minor (mCyR) - \>35 to 65% Ph+ metaphases; Minimal - \>65 to 95% Ph+ metaphases; None - \>95 to 100% Ph+ metaphases.
Outcome measures
| Measure |
Asciminib
n=103 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=62 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Complete Cytogenetic Response (CCyR) Rate at Scheduled Time Points
at Week 24
|
42 Participants
|
15 Participants
|
|
Complete Cytogenetic Response (CCyR) Rate at Scheduled Time Points
at Week 48
|
41 Participants
|
13 Participants
|
|
Complete Cytogenetic Response (CCyR) Rate at Scheduled Time Points
at Week 72
|
39 Participants
|
12 Participants
|
|
Complete Cytogenetic Response (CCyR) Rate at Scheduled Time Points
at Week 96
|
41 Participants
|
10 Participants
|
|
Complete Cytogenetic Response (CCyR) Rate at Scheduled Time Points
at Week 120
|
37 Participants
|
7 Participants
|
|
Complete Cytogenetic Response (CCyR) Rate at Scheduled Time Points
at Week 144
|
35 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: by 24, 48, 72, 96, 120 and 144 weeksPopulation: CCyR analysis set is a subset of FAS and included participants who were not in CCyR at baseline. FAS comprised of all randomized participants.
Cytogenic response included Complete, Partial, Major, Minor, Minimal and no response. Cytogenetic response was assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases; Partial (PCyR) - \>0 to 35% Ph+ metaphases; Major (MCyR) - 0 to 35% Ph+ metaphases; Minor (mCyR) - \>35 to 65% Ph+ metaphases; Minimal - \>65 to 95% Ph+ metaphases; None - \>95 to 100% Ph+ metaphases.
Outcome measures
| Measure |
Asciminib
n=103 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=62 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Complete Cytogenetic Response Rate by Scheduled Time Points
by Week 24
|
42 Participants
|
15 Participants
|
|
Complete Cytogenetic Response Rate by Scheduled Time Points
by Week 48
|
47 Participants
|
22 Participants
|
|
Complete Cytogenetic Response Rate by Scheduled Time Points
by Week 72
|
49 Participants
|
22 Participants
|
|
Complete Cytogenetic Response Rate by Scheduled Time Points
by Week 96
|
51 Participants
|
22 Participants
|
|
Complete Cytogenetic Response Rate by Scheduled Time Points
by Week 120
|
51 Participants
|
22 Participants
|
|
Complete Cytogenetic Response Rate by Scheduled Time Points
by Week 144
|
51 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: at Weeks 36, 48, 60, 72, 84, 108, 120, 132, 144 & 156Population: Full Analysis Set (FAS): The FAS comprised of all randomized participants.
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 international scale (IS) as measured by RQ-PCR.
Outcome measures
| Measure |
Asciminib
n=157 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=76 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96
at Week 36
|
41 Participants
|
9 Participants
|
|
Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96
at Week 48
|
46 Participants
|
10 Participants
|
|
Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96
at Week 60
|
52 Participants
|
11 Participants
|
|
Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96
at Week 72
|
52 Participants
|
12 Participants
|
|
Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96
at Week 84
|
50 Participants
|
10 Participants
|
|
Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96
at Week 108
|
53 Participants
|
11 Participants
|
|
Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96
at Week 120
|
57 Participants
|
8 Participants
|
|
Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96
at Week 132
|
58 Participants
|
8 Participants
|
|
Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96
at Week 144
|
59 Participants
|
7 Participants
|
|
Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96
at Week 156
|
53 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: by Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 & 156, OverallPopulation: Full Analysis Set (FAS): The FAS comprised of all randomized participants.
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 international scale (IS) as measured by RQ-PCR. Overall time point has the count indicating participants achieving MMR at any time during the study.
Outcome measures
| Measure |
Asciminib
n=157 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=76 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 4
|
3 Participants
|
0 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 8
|
12 Participants
|
4 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 12
|
30 Participants
|
7 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 16
|
39 Participants
|
8 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 24
|
43 Participants
|
11 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 36
|
51 Participants
|
13 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 48
|
55 Participants
|
15 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 60
|
60 Participants
|
16 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 72
|
60 Participants
|
17 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 84
|
63 Participants
|
17 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 96
|
67 Participants
|
18 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 108
|
67 Participants
|
18 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 120
|
68 Participants
|
18 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 132
|
70 Participants
|
18 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 144
|
71 Participants
|
18 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
by Week 156
|
71 Participants
|
18 Participants
|
|
Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points
Overall
|
74 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 216 WeeksPopulation: MMR responder set is a subset of FAS and included participants who achieved MMR at any time on randomized treatment. FAS comprised of all randomized participants.
Time to MMR was defined as the time from the date of randomization to the date of the first documented MMR.
Outcome measures
| Measure |
Asciminib
n=74 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=19 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Time to Major Molecular Response (MMR)
|
16.3 Weeks
Interval 4.0 to 216.0
|
24.1 Weeks
Interval 7.0 to 216.0
|
SECONDARY outcome
Timeframe: 216 WeeksPopulation: MMR responder set included participants who achieved MMR at any time on randomized treatment. FAS comprised of all randomized participants.
Duration of MMR was defined as the time from the date of first documented MMR to the earliest date of loss of MMR, progression to Accelerated phase (AP) or Blast crisis (BC), or Chronic myeloid leukemia (CML)-related death.
Outcome measures
| Measure |
Asciminib
n=74 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=19 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Duration of Major Molecular Response (MMR)
|
NA Weeks
NA: Not estimable due to insufficient events observed
|
NA Weeks
NA: Not estimable due to insufficient events observed
|
SECONDARY outcome
Timeframe: 216 WeeksPopulation: CCyR responder set was a subset of FAS and included patients who did not have CCyR at baseline and achieved CCyR at any time on randomized treatment. FAS comprised of all randomized participants.
Time to CCyR was defined as the time from the date of randomization to the date of the first documented CCyR.
Outcome measures
| Measure |
Asciminib
n=52 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=22 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Time to Complete Cytogenetic Response Rate (CCyR) Among Participants Who Achieved CCyR
|
24.3 Weeks
Interval 23.0 to 216.0
|
24.3 Weeks
Interval 12.0 to 53.0
|
SECONDARY outcome
Timeframe: 144 weeksPopulation: CCyR responder set was a subset of FAS and included patients who did not have CCyR at baseline and achieved CCyR at any time on randomized treatment. FAS comprised of all randomized participants.
Duration of CCyR was defined as the time between date of first documented CCyR and the earliest date of loss of CCyR, progression to AP/BC, or CML-related death for participants in the Cytogenetic Responder Set. The time was censored at the last cytogenetic assessment date on treatment for participants for whom none of the events was reported or last PCR evaluation on treatment indicating MMR.
Outcome measures
| Measure |
Asciminib
n=52 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=22 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Duration of Complete Cytogenetic Response (CCyR)
|
NA Weeks
NA: Not estimable due to insufficient events observed
|
NA Weeks
Interval 64.1 to
NA: Not estimable due to insufficient events observed
|
SECONDARY outcome
Timeframe: From the first dose of treatment up to 5 years, through treatment completion, an average of 2.3 years, approximatelyPopulation: Full Analysis Set (FAS): The FAS comprised of all randomized participants.
TTF was defined as the time from date of randomization to an event of treatment failure. Treatment failure was defined as meeting a lack of efficacy criterion or discontinuing treatment due to any reason.
Outcome measures
| Measure |
Asciminib
n=157 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=76 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Time to Treatment Failure (TTF)
|
2.4 Year
Interval 1.0 to
NA: Not estimable due to insufficient events observed
|
0.5 Year
Interval 0.5 to 0.6
|
SECONDARY outcome
Timeframe: From the first dose of treatment up to study completion, up to 5 yearsPopulation: The Full Analysis Set (FAS) comprised of all randomized participants. According to the intent to treat principle, participants were analyzed according to the treatment and stratum were assigned at randomization.
Progression-free survival was defined as the time from the date of randomization to the earliest occurrence of documented disease progression to AP/BC or the date of death from any cause (including progressions and deaths observed during the survival follow-up period), per Kaplan-Meier.
Outcome measures
| Measure |
Asciminib
n=157 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=76 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Progression Free Survival Per Percentage Event-free Kaplan-Meier Estimates
1 year
|
95.6 Percentage of participants
Interval 90.4 to 98.0
|
91.4 Percentage of participants
Interval 80.2 to 96.4
|
|
Progression Free Survival Per Percentage Event-free Kaplan-Meier Estimates
3 years
|
85.7 Percentage of participants
Interval 77.5 to 91.0
|
84.9 Percentage of participants
Interval 69.6 to 92.9
|
|
Progression Free Survival Per Percentage Event-free Kaplan-Meier Estimates
5 years
|
68.5 Percentage of participants
Interval 47.2 to 82.7
|
64.6 Percentage of participants
Interval 38.4 to 81.9
|
SECONDARY outcome
Timeframe: From the first dose of treatment to study completion, up to 5 yearsPopulation: The FAS comprised of all randomized participants. According to the intent to treat principle, participants were analyzed according to the treatment and stratum were assigned at randomization.
Overall survival is defined as the time from the date of randomization to the date of death (including the survival follow-up period) per Kaplan-Meier (KM).
Outcome measures
| Measure |
Asciminib
n=157 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
n=76 Participants
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Overall Survival (OS) Per Event Free Percentage Per Kaplan-Meier Estimates
1 year
|
97.3 Percentage of participants
Interval 92.9 to 99.0
|
98.6 Percentage of participants
Interval 90.2 to 99.8
|
|
Overall Survival (OS) Per Event Free Percentage Per Kaplan-Meier Estimates
3 years
|
92.4 Percentage of participants
Interval 86.7 to 95.7
|
96.9 Percentage of participants
Interval 88.0 to 99.2
|
|
Overall Survival (OS) Per Event Free Percentage Per Kaplan-Meier Estimates
5 years
|
89.4 Percentage of participants
Interval 83.1 to 93.5
|
90.0 Percentage of participants
Interval 78.9 to 95.4
|
SECONDARY outcome
Timeframe: Week 2 Day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dosePopulation: Participants in the Pharmacokinetic analysis set (PAS) with an available value for the outcome measure. PAS included all participants who provided at least one evaluable PK concentration of asciminib.
Measured concentration at the end of a dosing interval at steady state (taken directly before next administration)
Outcome measures
| Measure |
Asciminib
n=14 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
Trough Plasma Concentrations for Asciminib
|
238 ng/mL
Interval 145.0 to 551.0
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 1 at pre-dose, 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dosePopulation: Pharmacokinetic (PK) analysis set (PAS) included all participants who provided at least one evaluable PK concentration.
Maximum (peak) observed plasma concentration after dose administration (mass x volume-1).
Outcome measures
| Measure |
Asciminib
n=15 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
PK Parameter: Cmax for Asciminib
|
971 ng/mL
Geometric Coefficient of Variation 48.3
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dosePopulation: Pharmacokinetic (PK) analysis set (PAS) included all participants who provided at least one evaluable PK concentration.
Time to reach maximum (peak) plasma concentration after dose administration (time). Actual sampling times were taken into consideration for the pharmacokinetic analysis.
Outcome measures
| Measure |
Asciminib
n=15 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
PK Parameter: Tmax for Asciminib
|
1.92 hour (hr)
Interval 0.983 to 3.33
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dosePopulation: Participants in the Pharmacokinetic analysis set (PAS) with an available value for the outcome measure. PAS included all participants who provided at least one evaluable PK concentration of asciminib.
Area under the plasma concentration-time curve from time zero to 12 hours (mass x time x volume-1)
Outcome measures
| Measure |
Asciminib
n=14 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
PK Parameter: AUC0-12h for Asciminib
|
5810 ng*hr/mL
Geometric Coefficient of Variation 32.9
|
—
|
SECONDARY outcome
Timeframe: Week 2 day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dosePopulation: Participants in the Pharmacokinetic analysis set (PAS) with an available value for the outcome measure. PAS included all participants who provided at least one evaluable PK concentration of asciminib.
Total apparent body clearance of drug from the plasma after oral administration (volume x time-1).
Outcome measures
| Measure |
Asciminib
n=14 Participants
Participants randomized to asciminib 40mg BID
|
Bosutinib
Participants randomized to bosutinib 500mg QD
|
|---|---|---|
|
PK Parameter: CL/F for Asciminib
|
7.29 L/hr
Interval 3.73 to 11.5
|
—
|
Adverse Events
On-treatment Period Asciminib
Serious events: 34 serious events
Other events: 130 other events
Deaths: 5 deaths
On-treatment Period Bosutinib
Serious events: 20 serious events
Other events: 72 other events
Deaths: 1 deaths
On-treatment Period: Switched From Bosutinib to Asciminib
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Post-treatment Period Asciminib
Serious events: 1 serious events
Other events: 7 other events
Deaths: 11 deaths
Post-treatment Period Bosutinib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 8 deaths
Post-treatment Period: Switched From Bosutinib to Asciminib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
On-treatment Period Asciminib
n=156 participants at risk
On-treatment period of asciminib was from first day of exposure to asciminib to 30 days after the last exposure to asciminib.
|
On-treatment Period Bosutinib
n=76 participants at risk
On-treatment period Bosutinib was from first day of exposure to bosutinib to either 30 days after the last exposure to bosutinib or the day before the first administration of asciminib, whichever came first.
|
On-treatment Period: Switched From Bosutinib to Asciminib
n=25 participants at risk
On-treatment switch from bosutinib to asciminib period was from the first day of exposure to asciminib, from switching from bosutinib to asciminib, to 30 days after the last exposure to asciminib, after the switch.
|
Post-treatment Period Asciminib
n=135 participants at risk
Post-treatment period of asciminib started from Day 31 (31st day) of last exposure to asciminib until maximum of approx. 7 years.
|
Post-treatment Period Bosutinib
n=61 participants at risk
Post-treatment period started either from Day 31 (31st day) of last exposure to bosutinib or from first administration of asciminib (participants switching to asciminib) whichever came first, until maximum of approx. 7 years
|
Post-treatment Period: Switched From Bosutinib to Asciminib
n=24 participants at risk
Post-treatment switch from bosutinib to asciminib period started from the day after last exposure to asciminib for people who switched over to asciminib, until end of study or discontinuation from study.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Cardiac disorders
Atrial fibrillation
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Cardiac disorders
Cardiac arrest
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Cardiac disorders
Cardiac disorder
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Cardiac disorders
Cardiac failure
|
1.9%
3/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Eye disorders
Toxic optic neuropathy
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Mesenteric artery embolism
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Nausea
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Subileus
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Complication associated with device
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Death
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Hyperthermia
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Impaired healing
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Non-cardiac chest pain
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Pyrexia
|
1.3%
2/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Appendicitis
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
COVID-19
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Pneumonia
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Postoperative wound infection
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Septic shock
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Skin infection
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
3/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Urosepsis
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Investigations
Ejection fraction decreased
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Investigations
Platelet count decreased
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal metastasis
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Nervous system disorders
Central nervous system vasculitis
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Nervous system disorders
Cerebral disorder
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.74%
1/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Nervous system disorders
Cerebral infarction
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Nervous system disorders
Headache
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Nervous system disorders
Ischaemic stroke
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Nervous system disorders
Post-traumatic headache
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Nervous system disorders
Status epilepticus
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Product Issues
Device malfunction
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Psychiatric disorders
Anxiety
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Psychiatric disorders
Depression
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Psychiatric disorders
Major depression
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
3.9%
3/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
2.6%
2/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Vascular disorders
Aortic occlusion
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Vascular disorders
Deep vein thrombosis
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Vascular disorders
Haematoma
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
Other adverse events
| Measure |
On-treatment Period Asciminib
n=156 participants at risk
On-treatment period of asciminib was from first day of exposure to asciminib to 30 days after the last exposure to asciminib.
|
On-treatment Period Bosutinib
n=76 participants at risk
On-treatment period Bosutinib was from first day of exposure to bosutinib to either 30 days after the last exposure to bosutinib or the day before the first administration of asciminib, whichever came first.
|
On-treatment Period: Switched From Bosutinib to Asciminib
n=25 participants at risk
On-treatment switch from bosutinib to asciminib period was from the first day of exposure to asciminib, from switching from bosutinib to asciminib, to 30 days after the last exposure to asciminib, after the switch.
|
Post-treatment Period Asciminib
n=135 participants at risk
Post-treatment period of asciminib started from Day 31 (31st day) of last exposure to asciminib until maximum of approx. 7 years.
|
Post-treatment Period Bosutinib
n=61 participants at risk
Post-treatment period started either from Day 31 (31st day) of last exposure to bosutinib or from first administration of asciminib (participants switching to asciminib) whichever came first, until maximum of approx. 7 years
|
Post-treatment Period: Switched From Bosutinib to Asciminib
n=24 participants at risk
Post-treatment switch from bosutinib to asciminib period started from the day after last exposure to asciminib for people who switched over to asciminib, until end of study or discontinuation from study.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.3%
16/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
7.9%
6/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Asthenia
|
9.0%
14/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.2%
30/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
17.1%
13/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
36.0%
9/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.74%
1/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.1%
36/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
14.5%
11/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
32.0%
8/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.5%
2/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.0%
14/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
15.8%
12/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
7/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
6.6%
5/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Constipation
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
5.3%
4/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
20/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
72.4%
55/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
11/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
3.9%
3/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Nausea
|
11.5%
18/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
46.1%
35/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
16.0%
4/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
12/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
25.0%
19/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
8.0%
2/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Fatigue
|
15.4%
24/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
10.5%
8/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Influenza like illness
|
1.9%
3/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
5.3%
4/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Non-cardiac chest pain
|
5.8%
9/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Oedema peripheral
|
7.7%
12/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
2.6%
2/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
General disorders
Pyrexia
|
3.2%
5/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
7.9%
6/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
COVID-19
|
10.9%
17/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
6.6%
5/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Nasopharyngitis
|
11.5%
18/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
3.9%
3/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
13/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
5.3%
4/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.64%
1/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
8.0%
2/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Investigations
Alanine aminotransferase increased
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
30.3%
23/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
3.3%
2/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Investigations
Amylase increased
|
5.8%
9/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
5.3%
4/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Investigations
Aspartate aminotransferase increased
|
5.8%
9/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
21.1%
16/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.6%
1/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Investigations
Blood creatinine increased
|
3.8%
6/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
6.6%
5/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Investigations
Lipase increased
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
6.6%
5/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Investigations
Neutrophil count decreased
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
5.3%
4/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Investigations
Platelet count decreased
|
7.1%
11/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
6.6%
5/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.74%
1/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
7.9%
6/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.3%
2/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
5.3%
4/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.7%
23/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
2.6%
2/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.74%
1/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
12/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
3.9%
3/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.4%
10/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
3.9%
3/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
8.0%
2/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.6%
1/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.6%
15/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
6.6%
5/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Nervous system disorders
Dizziness
|
9.0%
14/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
2.6%
2/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Nervous system disorders
Headache
|
19.2%
30/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
15.8%
12/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
16.0%
4/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.74%
1/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Psychiatric disorders
Insomnia
|
7.1%
11/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
1.3%
1/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.0%
14/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
6.6%
5/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
5.3%
4/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
2.6%
2/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
2/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
5.3%
4/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.3%
2/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
8.0%
2/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
7.9%
6/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
6.6%
5/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
15/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
22.4%
17/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
8.0%
2/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.74%
1/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.1%
8/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
2.6%
2/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
4.0%
1/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
|
Vascular disorders
Hypertension
|
14.7%
23/156 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
5.3%
4/76 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/25 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.74%
1/135 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/61 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
0.00%
0/24 • Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER