Safety Results IIIa: TEAE by Adverse Events Distribution in JMP® Clinical

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In our recent paper, CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation^1,2, 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 evaluate SAEs by Adverse Events Narrative³ and Discontinuations Due to AEs⁴ by Adverse Events Distribution. We'll now look at the third step for Safety Results: Treatment Emergent Adverse Events (TEAE) and Adverse Reactions.  

The third step in Safety Results is to determine which common TEAEs (defined as an occurrence greater than 2%) are more frequently associated with drug treatment in the different treatment group. The reviewer remarked that the table was generated by JMP Clinical 6.1 in the FDA CR for Adhansia XR².

The tables at the bottom of Figure 4 in our paper¹ were generated via the Adverse Events Distribution report in JMP Clinical and used Nicardipine sample data. We can easily adjust the Overall Percent Occurrence to define the common TEAE, mostly 2% as in CR for Adhansia XR⁵ or 3% in other documents. Figure 4A shows the occurrence of all TEAEs, while Figure 4B shows a subset that includes the most common TEAEs with outcome as Not Recovered/Not Resolved colored by causality. The tables, in CR for Adhansia XR² and our paper, showed both counts and percentages for each group. The interactive distribution plots in the top of Figure 4 are another way to present the results.

References:

1. Mann, G. & Pedersen, T. J. & Lyzinski, R. & Scott, A. & Foglia, A. J. & Cromer, J. & Dong, M. & Varga, N. & Gardner, S. & Kirchberg, C. J. & Wingerd, B. A. & Wolfinger, R. D. & Bao, W., (2023) “CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation”, Journal of the Society for Clinical Data Management 3(1). https://doi.org/10.47912/jscdm.169
2. CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation published in JSCDM
3. Safety Results I: Death and SAE described by AE Narrative in JMP Clinical
4. Safety Results II: Discontinuations Due to AEs Evaluated by AE Distribution in JMP Clinical
5. NDA Adhansia XR 2019 https://www.fda.gov/media/124188/download