Safety Results IIIb: Significant Adverse Events by AE Risk Report 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 previous blogs demonstrated how to capture SAEs using Adverse Events Narrative3, and Discontinuations Due4 to AEs and TEAE5 with Adverse Events Distribution. There is a final step...