This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
Study Type
OBSERVATIONAL
Enrollment
31
Novartis
Basel, Switzerland
Major molecular response (MMR) at 6 months
Time frame: At 6 months
Major molecular response (MMR) by 6 months
Time frame: By 6 months
MMR at and by 3, 9, and 12 months
Time frame: At and by 3, 9, and 12 months
Complete cytogenic response (CCyR) at and by 3, 6, 9, and 12 months
Time frame: At and by 3, 6, 9, and 12 months
Complete hematologic response (CHR) at and by 3, 6, 9, and 12 months
Time frame: At and by 3, 6, 9, and 12 months
Time to first CCyR at and by 3, 6, 9, and 12 months
Time frame: At and by 3, 6, 9, and 12 months
Gender
Time frame: Baseline
Race
Time frame: Baseline
Time from CML diagnosis to study index (i.e., asciminib) start date
Time frame: Baseline
Country of residence
Time frame: Baseline
Status of CML at baseline
Time frame: Baseline
Number of patients per response type at asciminib start date
Response types were MMR, CCyR, and CHR.
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Time frame: Baseline
Stem-cell transplant performed status
Time frame: Baseline
Medical history by system-organ-class, preferred term from CML diagnosis to asciminib start date
Time frame: Baseline
Overall tyrosine kinase inhibitors (TKIs) prior to index date
Time frame: Baseline
Prior TKIs between CML diagnosis and T315I mutation diagnosis
Time frame: Baseline
Prior TKIs between T315I mutation diagnosis and index date
Time frame: Baseline
Sequence of prior TKI treatment patterns
Time frame: Baseline
Number of patients with response to prior TKIs from CML diagnosis to asciminib (index date)
Response types were MMR, CCyR, and CHR.
Time frame: Baseline
Number of patients with response to prior TKIs between CML diagnosis to T315I mutation diagnosis
Response types were MMR, CCyR, and CHR.
Time frame: Baseline
Number of patients with response to prior TKIs between T315I mutation diagnosis to asciminib start (index date)
Response types were MMR, CCyR, and CHR.
Time frame: Baseline
Number of patients with intolerance to prior TKIs, per category
Categories were discontinuation due to adverse events, relationship to treatment, and outcome.
Time frame: Baseline
Number of patients with intolerance to last TKI prior to asciminib, per category
Categories were discontinuation due to adverse events, relationship to treatment, and outcome.
Time frame: Baseline
Asciminib dose
Time frame: Up to 13 months
Asciminib discontinuation
Time frame: Up to 13 months
Duration of exposure to asciminib
Time frame: Up to 13 months