Page 105 - 2019_01-Haematologica-web

Pleural effusion in dasatinib-treated CML patients
Assessments
Pleural effusions were monitored continuously in treated patients who received at least 1 dose of study drug (DASISION [n=258], 034/Dose-optimization [n=662], pooled population
A
[n=2712]). Pleural effusion by first onset is presented by year for patients at risk (the number of patients who were treated within a year and did not have pleural effusion). Effusions were graded according to the Common Terminology Criteria for Adverse
B
C
Figure 1. Retrospective multivariate analysis to determine if there was an association between pleural effusion and potential risk factors. Odds ratios (ORs) with 95% confidence intervals (CIs) are shown for potential predictive variables listed for patients with CML-CP treated with 100 mg QD dasatinib from DASISION (A), 034/Dose-optimization (B), or both DASISION and 034/Dose-optimization (C). AFRI: Africa; CA: Caribbean; CML-CP: chronic myeloid leukemia in chronic phase; EU: European Union; MMR: major molecular response, BCR-ABL1 transcripts ≤0.1% on the International Scale (IS) corresponding to a 3-log reduction from a standardized baseline; MR4: BCR-ABL1 transcripts <0.01% (IS) corresponding to a 4-log reduction from a standardized baseline; MR4.5: BCR-ABL1 transcripts ≤0.0032% (IS) cor- responding to a 4.5-log reduction from a standardized baseline; NA: North America; PE: pleural effusion; QD: once daily.
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