OTHER TERMINOLOGY MedDRA Version 14.0 Reported Coded Term Body PT SOC Event (% subjects) System/SOC (% subjects) (% subjects) (% subjects) (% subjects) Hyperglycaemia Metabolism (4.1) Hyperglycaemia and nutrition Increased (4.1) disorders blood sugar (4.1) Metabolism (2.7) Hyperglycemia & nutritional Glucose (10.5) disorders increased (2.2) (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 “disorder SOC”; Investigations SOC MedDRA Version 13.1 Number of Events at PT Level Malignant neoplasm progression (PT) 15 Neoplasm malignant 5 MedDRA Version 14.0 Number of Events at PT Level Malignant neoplasm progression (no 0 longer a PT) Neoplasm malignant 20
OTHER TERMINOLOGY MedDRA Version 14.0 Reported Event (% subjects) Coded Term (% subjects) Body System/SOC (% subjects) PT (% subjects) SOC (% subjects) Hyperglycaemia (4.1) Hyperglycemia (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 MedDRA Version 13.1 Number of Events at PT Level Malignant neoplasm progression (PT) 15 Neoplasm malignant 5 MedDRA Version 14.0 Number of Events at PT Level Malignant neoplasm progression (no longer a PT) 0 Neoplasm malignant 20
9610-1400_datretptc_r3_1_mar2011.docx