David Goldsmith; Sidney Kahn; Pharmaceutical Research and Anna-Lisa Kleckner; Susan M. Lorenski; Manufacturers of America JoAnn Medbery; Margaret M. Westland† Miles Braun; Andrea Feight; US Food and Drug Administration John (Jake) Kelsey†; Brad Leissa; Toni Piazza-Hepp Former Rapporteur † Figures OTHER TERMINOLOGY MedDRA Version 19.0 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. Example as of MedDRA Version 19.0. OTHER TERMINOLOGY MedDRA Version 19.0 Reported Event Coded Term Body PT SOC System/SOC (% subjects) (% subjects) (% subjects) (% subjects) (% subjects) Hyperglycaemia Hyperglycaemia Hyperglycaemia Metabolism & Metabolism and (4.1) (10.5) (4.1) nutritional nutrition
Pharmaceutical Research and Manufacturers of America David Goldsmith; Sidney Kahn; Anna-Lisa Kleckner; Susan M. Lorenski; JoAnn Medbery; 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 19.0 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. Example as of MedDRA Version 19.0. OTHER TERMINOLOGY MedDRA Version 19.0 Reported Event (% subjects) Coded Term (% subjects) Body System/SOC (% subjects) PT (% subjects) SOC (% subjects) Hyperglycaemia (4.1) Hyperglycaemia (10.5) Metabolism & nutritional Hyperglycaemia (4.1) Metabolism and nutrition
9610-1910_datretptc_r3_12_sep2016.docx