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 (4.1) Hyperglycaemia and nutrition (4.1) Increased blood disorders (4.1) sugar (2.7) Metabolism & Glucose Hyperglycaemia nutritional increased (2.2) (10.5) disorders (10.5) Blood glucose Blood glucose Investigations high (1.0) increased (6.4) (6.4) Increasing glucoses (0.5) Figure 2 Multiple MedDRA terms may be used to code similar medical conditions – included in a associated laboratory findings are in SOC “disorder SOC”; Investigations
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) Glucose increased (2.2) Blood glucose high (1.0) Blood glucose increased (6.4) Investigations (6.4) Increasing glucoses (0.5) Figure 2 – Multiple MedDRA terms may be used to code similar medical conditions included in a “disorder SOC”; associated laboratory findings are in SOC Investigations