Chapter 1 24 Data were collected through an electronic data collection system (EDC), Castor, that is compliant with all regulatory requirements for a marketing authorization submission. Safety was monitored through standard pharmacovigilance practices. Efficacy was primarily analyzed by in-hospital physician-assessed evaluation of healing of the lesions within 28 or 42 days. Additionally, the assessments could be confirmed by taking both measurements (width times heigh) and photographs of lesions before, during, and after treatment. The difference in design between the trial and expanded access program led to various choices regarding analysis sets. For example, all patients could be analyzed, including those that were previously treated with pritelivir, hence including patents that had six different courses within the expanded access program multiple times. Else, one could opt to only analyze patients naïve to pritelivir– even excluding patients that had prior successfully been treated in the randomized trial. Results With a data cut-off on December 28th, 2022, we analyzed all requests for treatment through expanded access that were received through the online data collection program managed by myTomorrows.The number of requests and subsequently initiated treatment and assessed results are visualized in the flowchart in Figure 2. Figure 2: Flowchart of the expanded access program of pritelivir requests and outcomes.
RkJQdWJsaXNoZXIy MTk4NDMw