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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