Treatment emergent signs and symptoms TESS

In guidance document ICH E3, Structure and Content of Clinical Study Reports, the FDA defines treatment-emergent signs and symptoms (TESS) as events not seen at baseline and events that worsened even if present at baseline. As simple as that may sound, it can sometimes be quite difficult to program. The important data variables that come into play are dosing record dates and times, adverse event start and stop times, and adverse event severity. All of these data variables need to be completed accurately for TESS to be calculated properly. 

Table 23.1 Illustration of treatment emergent signs and symptoms (TESS). In the crossclassification by baseline and outcome, patients with TESS nnmber c for the experimental group and g for the control gronp. Thus c patients with TESS out of on the one hand are compared with g patients out of on the other. A more conventional analysis would compare a + c patients with adverse events in the treatment group with e -I- g in the control group. A more sophisticated analysis might stratify by baseline state and compare treatment and control using the Mantel-Haenszel procednre.

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