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 Metastatic pain 15 0 In MedDRA Version 18.1, Metastatic pain was a PT and in (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 – – Example as of MedDRA Version 18.1 and 19.0 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 2 MedDRA Version 2 Internationally Agreed English Alphabetical Order Blood and lymphatic system disorders Infections and infestations Neoplasms benign, malignant and unspecified Cardiac disorders (incl cysts and polyps) Congenital, familial and genetic disorders Blood and lymphatic system disorders Ear and labyrinth disorders Immune system disorders Endocrine disorders Endocrine disorders
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 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 Example as of MedDRA Version 18.1 and 19.0 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 2 English Alphabetical Order MedDRA Version 2 Internationally Agreed Blood and lymphatic system disorders Infections and infestations Cardiac disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) Congenital, familial and genetic disorders Blood and lymphatic system disorders Ear and labyrinth disorders Immune system disorders Endocrine disorders Endocrine disorders