Keywords: safety, graphics, patient profiles
Standard safety assessments in a typical clinical trial include the reporting of adverse events and collection of numerous laboratory, vital sign, and ECG parameters at several time points during treatment. This results in longitudinal data on multiple parameters, and for many of these parameters even small shifts from baseline or differences between investigational drug and comparator can be clinically relevant. Often the analyses of these parameters are restricted to descriptive summaries, resulting in lengthy tabulations in which subtle signals and rare events may be missed. Graphics are widely used in the presentation of efficacy endpoints, but their application to safety data is not as common. We propose a set of “must-have” graphics that, when added to the analyses for a clinical study report or integrated analysis of safety, can assist in discerning if safety signals are present in the data. We also present a patient-profile plot that can assist in the clinical review of SAEs or adverse events of special interest when AEs, medications, medical history and continuous parameters must be considered in relationship to one another when assessing the effect of study drug.