The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory authority can manage the marketing approval properly.
Study Type
OBSERVATIONAL
Enrollment
670
Local Institution
Seoul, South Korea
Adverse events occurrence
Time frame: 30 days after last dose of study drug
Improvement in hematologic response
The number and percentage of subjects who satisfy each criterion of hematologic responses (Complete/No response) will be presented as frequency distribution. McNemar test will be conducted to test the change from the baseline value
Time frame: 4 weeks after registration
Improvement in cytogenetic response
The number and percentage of subjects who satisfy each criterion of cytogenetic responses (Complete/Partial/Minor/Minimal/No response) will be presented as frequency distribution. McNemar test will be conducted to test the change from the baseline value
Time frame: 12 weeks after registration
Overall efficacy assessment by investigator's discretion
Based on demographic factors, treatment factors like medical history and concomitant medication
Time frame: 4 weeks after registration
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