Clinical Impact of Adverse Event Reporting
Table 4:
Useful Factors for Assessing Causal Relationship Between Drug and Reported Adverse
Events(40)
- Chronology of administration of agent, including beginning and ending of treatment and
adverse event onset
- Course of adverse event when suspected agent stopped [dechallenge] or
continued
- Etiologic roles of agents and diseases in regard to adverse event
- Response to readministration [rechallenge] of agent
- Laboratory test results
- Previously known toxicity of agent
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