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 associated laboratory findings are in SOC Investigations “disorder SOC”; Events/Cases Preferred Terms Comment Version 18.1 Version 19.0 Metastatic pain 15 0 In MedDRA Version 18.1, was a PT and in Metastatic pain (no longer a PT) Version 19.0 it was demoted to an Cancer pain 5 20 LLT under PT Cancer pain Figure 3 Impact of MedDRA version changes demotion of a PT – – Figure 4 Primary SOC output listing, MedDRA Version 17.1 example. Note that some – – PTs are multiaxial, however, this figure shows only the primary SOC assignments MedDRA Version 19.0 MedDRA Version 19.0 Internationally Agreed Order English Alphabetical Order Blood and lymphatic system disorders Infections and infestations Neoplasms benign, malignant and unspecified Cardiac disorders (incl cysts and polyps)
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 Preferred Terms Events/Cases Comment Version 18.1 Version 19.0 Metastatic pain 15 0 (no longer a PT) In MedDRA Version 18.1, Metastatic pain was a PT and in Version 19.0 it was demoted to an LLT under PT Cancer pain Cancer pain 5 20 Figure 3 – Impact of MedDRA version changes – demotion of a PT Figure 4 – Primary SOC output listing, MedDRA Version 17.1 – example. Note that some PTs are multiaxial, however, this figure shows only the primary SOC assignments MedDRA Version 19.0 English Alphabetical Order MedDRA Version 19.0 Internationally Agreed Order Blood and lymphatic system disorders Infections and infestations Cardiac disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps)