FIGURE 1.

MedDRA hierarchy. From reported AEs, verbatim information is linked to a Lowest Level Term. Each Lowest Level Term is linked to a parent Preferred Term that is a distinct descriptor for a symptom, sign, disease diagnosis, therapeutic indication, investigation, surgical or medical procedure, or medical, social or family history characteristic. Related Preferred Terms are grouped into High Level Terms based upon anatomy, pathology, physiology, aetiology or function. High Level Terms, related by anatomy, pathology, physiology, aetiology or function are linked to High Level Group Terms. High Level Groups Terms are grouped into System Organ Classes based on aetiology, manifestation site or purpose. AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities