Review by Joseph Ross – 02/25/2021 – 4:45pm

Data Request Number: 2021-4575 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

Interesting project to to develop a novel method for summarizing and comparing class-related safety in order to inform future schizophrenia drug development. While the methods used to create an integrated summary of safety events among patients enrolled in the risperidone trials are straightforward, as are the methods used to create a table with all AE Preferred terms and their EBGM value for antipsychotics, no information is provided on how the authors plan to compare these two tables. How will they conclude whether the FAERs data represent a reasonable proxy for safety given the AEs experienced in the trial? Or is the only purpose to estimate the proportion of subjects in each clinical study having an AE Preferred Term as a cumulative function of each Preferred Term’s class-related risk in real-world reporting database FAERS? The proposal would be strengthened by making this more clear.

Recommendation for this data request: Approve