Reported LLT Selected Comment Death due to Myocardial infarction myocardial infarction Constipation Constipation, ruptured Perforated bowel Record death as bowel, peritonitis, sepsis; Peritonitis an outcome patient died Sepsis 3.2.2 Death as the only reported information If the only information reported is death, select the most specific death term available. Circumstances of death should not be inferred but recorded only if stated by the reporter. Death terms in MedDRA are linked to HLGT Fatal outcomes. Example Reported LLT Selected Patient was found dead Found dead Patient died in childbirth Maternal death during childbirth The autopsy report stated that the Death from natural causes cause of death was natural 3.2.3 Death terms that add important clinical information Death terms that add important clinical information should be selected along with any reported ARs/AEs. Example Reported LLT Selected Patient experienced a rash and had Rash sudden cardiac death Sudden cardiac death 3.2.4 Other patient outcomes (non-fatal) Hospitalization, disability and other patient outcomes are not generally considered ARs/AEs.
Reported LLT Selected Comment Death due to myocardial infarction Myocardial infarction Record death as an outcome Constipation, ruptured bowel, peritonitis, sepsis; patient died Constipation Perforated bowel Peritonitis Sepsis 3.2.2 Death as the only reported information If the only information reported is death, select the most specific death term available. Circumstances of death should not be inferred but recorded only if stated by the reporter. Death terms in MedDRA are linked to HLGT Fatal outcomes. Example Reported LLT Selected Patient was found dead Found dead Patient died in childbirth Maternal death during childbirth The autopsy report stated that the cause of death was natural Death from natural causes 3.2.3 Death terms that add important clinical information Death terms that add important clinical information should be selected along with any reported ARs/AEs. Example Reported LLT Selected Patient experienced a rash and had sudden cardiac death Rash Sudden cardiac death 3.2.4 Other patient outcomes (non-fatal) Hospitalization, disability and other patient outcomes are not generally considered ARs/AEs.
9491-1600_termselptc_r4_5_mar2013.docx