Piazza-Hepp Former Rapporteur † 6.3 Figures – OTHER TERMINOLOGY No. of MedDRA Version 17.0 No. of PREFERRED TERMS EVENTS PREFERRED TERMS EVENTS 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 Skin 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 17.0 Reported Event Coded Term Body PT SOC (% subjects) (% subjects) System/SOC (% subjects) (% subjects) (% subjects) Hyperglycaemia Metabolism (4.1) Hyperglycaemia and nutrition Increased blood (4.1) disorders (4.1) sugar (2.7) Metabolism & Glucose Hyperglycaemia nutritional increased (2.2) (10.5) disorders Blood glucose (10.5) Blood glucose Investigations high (1.0) increased (6.4) (6.4) Increasing glucoses (0.5)
Piazza-Hepp † Former Rapporteur 6.3 – Figures OTHER TERMINOLOGY PREFERRED TERMS No. of EVENTS MedDRA Version 17.0 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 Skin 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 17.0 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) Glucose increased (2.2) Blood glucose high (1.0) Blood glucose increased (6.4) Investigations (6.4) Increasing glucoses (0.5)
9610-1700_DatRetPTC_R3.7_mar2014.docx