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 Term Body PT SOC System/SOC (% subjects) (% subjects) (% subjects) (% subjects) (% subjects) Hyperglycaemia Metabolism and (4.1) Hyperglycaemia nutrition (4.1) Increased blood Metabolism & disorders (4.1) sugar (2.7) Hyperglycaemia nutritional (10.5) disorders Glucose increased (10.5) (2.2) Blood glucose high (1.0)
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) 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)
000157_datretptc_r3_15_mar2018.docx