Laboratory Abnormality Test Results Constitute Adverse Events

[sunnyman101]

The evaluation of laboratory data involves much more than deciding if an abnormal laboratory result is far enough out of range to be of concern. A laboratory result is never considered in isolation, but in the context of the patient’s physical examination and available history (e.g., past and present medical conditions, family medical history, concomitant and concurrent medications, and previous laboratory tests). But, could we use a graphical application on the assessment of abnormal laboratory values or test results constituting adverse events? For examples, bleeding due to abnormal INR range and/or thrombocytopenia; infection due to neutropenia.
For example, with the statistical application in Volcano plot (see screen shot attached) linking the red arrows indicate points-of-interest that display both large magnitude fold-changes (x axis) and high statistical significance (-log10 of p value, y axis) to the subject’s adverse events/medical history/concomitant and concurrent medication etc.