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 Metabolism and (4.1) Hyperglycaemia nutrition (4.1) Increased blood disorders (4.1) sugar (2.7) Metabolism & Glucose increased Hyperglycaemia nutritional (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. Preferred Terms Comment MedDRA MedDRA Version Version 18.1 19.0 Metastatic pain 15 0 (no longer a PT)
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 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 Comment MedDRA Version 18.1 MedDRA Version 19.0 Metastatic pain 15 0 (no longer a PT)
000011_datretptc_r3_13_mar2017.docx