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Coding Death, in Pharmacovigilance

Death - Event or outcome?

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

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