Generic Assessment of Side Effects (GASE)

The Generic Assessment of Side Effects (GASE) allows the assessment of side effects / adverse events in clinical trials. It asks for the typical side effects according to statistics of the National Institute of Health (NIH), but added some other items with critical relevance. It can be extended with diagnosis-specific and intervention-specific items according to the purpose of the study. Further, it allows outcome scores that either just reflect symptom load, or symptom load that is attributed to the intervention. The GASE was also introduced to encourage baseline assessments of symptom load, before interventions start. This allows a scientific detection of symptoms that are really attributable to the intervention, versus symptoms that already pre-existed before the intervention starts. With a reference data set of 2,500 participants, the GASE offers an orientation of how frequent the symptoms are in the general population. Meanwhile, this instrument is in use in various clinical trials.