Record patient age in a demographic Pancreatitis field. In Neonatal disorder addition, select LLT Neonatal disorder. 3.7 Body Site vs. Event Specificity – 3.7.1 MedDRA term includes body site and event information Example Reported LLT Selected Skin rash on face Rash on face 3.7.2 No available MedDRA term includes both body site and event information Select a term for the event, rather than a term that reflects a non-specific condition at the body site; in other words, the event information generally has priority. Example Reported LLT Selected Comment In this instance, there Skin rash on chest Skin rash is no available term for a skin rash on the chest However, medical judgment is required, and sometimes, the body site information should have priority as in the example below. Example Reported LLT Selected Comment Cyanosis implies a Cyanosis at injection site Injection site reaction generalized disorder. In this example,
Pancreatitis Neonatal disorder Record patient age in a demographic field. In addition, select LLT Neonatal disorder. 3.7 – Body Site vs. Event Specificity 3.7.1 MedDRA term includes body site and event information Example Reported LLT Selected Skin rash on face Rash on face 3.7.2 No available MedDRA term includes both body site and event information Select a term for the event, rather than a term that reflects a non-specific condition at the body site; in other words, the event information generally has priority. Example Reported LLT Selected Comment Skin rash on chest Skin rash In this instance, there is no available term for a skin rash on the chest However, medical judgment is required, and sometimes, the body site information should have priority as in the example below. Example Reported LLT Selected Comment Cyanosis at injection site Injection site reaction Cyanosis implies a generalized disorder. In this example,
9491-1610_termselptc_r4.6_sep2013.docx