Prevention and prophylaxis When an indication for prevention or prophylaxis is reported, select the specific MedDRA term, if it exists (Note: the words and are synonymous in the “prevention” “prophylaxis” context of MedDRA). Example Reported LLT Selected Prophylaxis of arrhythmia Arrhythmia prophylaxis Prevention of migraine Migraine prophylaxis If there is no MedDRA term containing or choose one of the “prevention” “prophylaxis”, following options. The preferred option is to select a general prevention/ prophylaxis term and a term for the condition. Alternatively, select a term for the condition alone or a prevention/prophylaxis term alone. Example Preferred Reported LLT Selected Comment Option Prevention Represents both the prevention/prophylaxis Hepatotoxicity concept and the condition Prevention of Represents Hepatotoxicity hepatotoxicity the condition Represents the Prevention prevention/prophylaxis concept Procedures and diagnostic tests as indications Select the appropriate term if the product is indicated for performing a procedure or a diagnostic test. Example Reported LLT Selected Induction of anaesthesia Induction of anaesthesia Contrast agent for angiogram Angiogram Contrast agent for coronary angiogram Coronary angiogram
Prevention and prophylaxis When an indication for prevention or prophylaxis is reported, select the specific MedDRA term, if it exists (Note: the words “prevention” and “prophylaxis” are synonymous in the context of MedDRA). Example Reported LLT Selected Prophylaxis of arrhythmia Arrhythmia prophylaxis Prevention of migraine Migraine prophylaxis If there is no MedDRA term containing “prevention” or “prophylaxis”, choose one of the following options. The preferred option is to select a general prevention/ prophylaxis term and a term for the condition. Alternatively, select a term for the condition alone or a prevention/prophylaxis term alone. Example Reported LLT Selected Preferred Option Comment Prevention of hepatotoxicity Prevention Hepatotoxicity Represents both the prevention/prophylaxis concept and the condition Hepatotoxicity Represents the condition Prevention Represents the prevention/prophylaxis concept Procedures and diagnostic tests as indications Select the appropriate term if the product is indicated for performing a procedure or a diagnostic test. Example Reported LLT Selected Induction of anaesthesia Induction of anaesthesia Contrast agent for angiogram Angiogram Contrast agent for coronary angiogram Coronary angiogram
000012_termselptc_r4_13_mar2017.docx