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Safety Information

Revised: 3 July 2013

Adverse Reaction Reporting - Definition of Causality

Certain:
  • the event occurred with a plausible time relationship to medicine use;
  • it could not be explained by concurrent diseases, or other medicines or substances;
  • withdrawal of the medicine resulted in recovery or significant improvement, and reinitiation ("rechallenge") of the medicine, if it was appropriate, resulted in recurrence of the same event; and
  • the event was a recognisable pharmacological action of the medicine or a clearly identifiable clinical event.
Probable:
the occurrence of the event was temporally associated with administration of the medicine, it was unlikely to be caused by a concurrent disease or other medicine or substance, and withdrawal of the medicine resulted in improvement or recovery.
Possible:
the occurrence of the event was temporally associated with administration of the medicine, but it could also be explained by concurrent disease or other medicine or substance, and/or details such as administration dates or response to withdrawal of the medicine may have been absent or unclear.
Unlikely:
the event occurred at a time in relation to medicine administration which made causation improbable. Concurrent disease or other medicine or substance may have provided a plausible explanation.
Unclassified:
more data were required in order to assess the adverse event.
Unclassifiable:
the data available were insufficient or contradictory, and it was not possible to obtain further data or verify existing data.

 

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