Safety Results II: Discontinuations due to AEs evaluated by AE Distribution in JMP® Clinical
In our recent paper, CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation1,2, we followed FDA NDA (New Drug Application) or CR (Clinical Reviews) templates to show how drug safety can be evaluated. My blog, Safety Result I, explained how to use the Adverse Events Narrative to summarize the individual information3 for those subjects that had a SAE in CR for Latuda4. The below fi...