Death is an outcome and not usually considered an adverse event or reaction. If events are reported along with death, select terms for the event. Record the fatal outcome in an appropriate data field.
Examples:
Reported - Death due to myocardial infarction
LLT Selected - Myocardial infarction
Outcome: Fatal
Reported - Constipation, ruptured bowel, peritonitis, sepsis; patient died
LLT Selected - Constipation, Perforated bowel, Peritonitis, Sepsis
Outcome: Fatal
Reported - Patient experienced a rash and had sudden cardiac death
LLT Selected - Rash, Sudden cardiac death
MedDRA Coding when Death is 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.
Reported Term Vs Coding
The patient was found dead - Code Found dead
The patient died during childbirth - Code Maternal death during childbirth
The autopsy report stated that the cause of death was natural - Code Death from natural causes