David Goldsmith; Sidney Kahn; Anna-Lisa Pharmaceutical Research and Kleckner; Susan M. Lorenski; Margaret M. Manufacturers of America Westland† Miles Braun; Andrea Feight; John (Jake) US Food and Drug Administration Kelsey†; Brad Leissa; Toni Piazza-Hepp Former Rapporteur † Figures OTHER TERMINOLOGY MedDRA Version 18.0 No. of No. of EVENTS EVENTS PREFERRED TERMS PREFERRED TERMS Infection 15 Upper respiratory tract 7 infection Nasopharyngitis 2 Infection 1 Lower respiratory tract 4 infection Skin infection 1 Abdominal pain 9 Abdominal pain 4 Abdominal pain upper 3 Abdominal tenderness 2 Accidental injury 4 Injury 1 Laceration 1 Ligament sprain 1 Back injury 1 Figure 1 How data coded to a single concept from another terminology may be – expressed by several PTs in MedDRA OTHER TERMINOLOGY MedDRA Version 18.0 Reported Event Coded Term Body PT SOC System/SOC (% subjects) (% subjects) (% subjects) (% subjects) (% subjects) Hyperglycaemia Metabolism & Metabolism and (4.1) Hyperglycaemia Hyperglycaemia nutritional nutrition (10.5) (4.1) Increased blood disorders (10.5) disorders (4.1) sugar (2.7)
Pharmaceutical Research and Manufacturers of America David Goldsmith; Sidney Kahn; Anna-Lisa Kleckner; Susan M. Lorenski; Margaret M. Westland† US Food and Drug Administration Miles Braun; Andrea Feight; John (Jake) Kelsey†; Brad Leissa; Toni Piazza-Hepp † Former Rapporteur Figures OTHER TERMINOLOGY PREFERRED TERMS No. of EVENTS MedDRA Version 18.0 PREFERRED TERMS No. of EVENTS Infection 15 Upper respiratory tract infection Nasopharyngitis Infection Lower respiratory tract infection Skin infection 7 2 1 4 1 Abdominal pain 9 Abdominal pain Abdominal pain upper Abdominal tenderness 4 3 2 Accidental injury 4 Injury Laceration Ligament sprain Back injury 1 1 1 1 Figure 1 – How data coded to a single concept from another terminology may be expressed by several PTs in MedDRA OTHER TERMINOLOGY MedDRA Version 18.0 Reported Event (% subjects) Coded Term (% subjects) Body System/SOC (% subjects) PT (% subjects) SOC (% subjects) Hyperglycaemia (4.1) Hyperglycaemia (10.5) Metabolism & nutritional disorders (10.5) Hyperglycaemia (4.1) Metabolism and nutrition disorders (4.1) Increased blood sugar (2.7)