Abdominal tenderness 2 Accidental injury 4 Injury 1 Laceration 1 Ligament sprain 1 Back injury 1 Figure 1 How data 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 Coded Term Body PT SOC System/SOC (% subjects) (% subjects) (% subjects) (% subjects) (% subjects) Hyperglycaemia Metabolism and (4.1) Hyperglycaemia nutrition (4.1) Increased blood disorders (4.1) sugar (2.7) Metabolism & Hyperglycaemia nutritional Glucose increased (2.2) (10.5) disorders (10.5) Blood glucose high Blood glucose Investigations (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 SOC”; associated laboratory findings are in SOC Investigations. “disorder Example as of MedDRA Version 19.0. Events/Cases Preferred Terms Comment MedDRA MedDRA Version Version 18.1 19.0
Abdominal tenderness 2 Accidental injury 4 Injury Laceration Ligament sprain Back injury 1 1 1 1 Figure 1 – How data 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 (% 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. Example as of MedDRA Version 19.0. Preferred Terms Events/Cases Comment MedDRA Version 18.1 MedDRA Version 19.0
000099_datretptc_r3_14_sep2017_rl_0.docx