cancel
Showing results for 
Show  only  | Search instead for 
Did you mean: 
Safety Results IIIa: TEAE by Adverse Events 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 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.

Wenjun_Bao_JMP_0-1694633288973.png

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.

Wenjun_Bao_JMP_1-1694633289005.png

 

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
Last Modified: Sep 20, 2023 2:51 PM