Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia in Subjects Who Experienced Clinical Benefit on Protocol CA180-002
Abstract
To determine the long term safety and tolerability of dasatinib exposure in subjects previously treated in CA180-002.
Conditions: Leukemia.
Primary outcome: Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation.; Number of Participants Who Experienced Drug-related AEs and Drug-related SAEs.; Number of Participants With Grade 3-4 Hematology Abnormalities; Number of Participants With Grade 3-4 Serum Chemistry Abnormalities; Number of Participants With Dose Interruptions and Dose Reductions.
Enrollment: 46 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 46 participants or records.
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