Adverse effects of treatment

♦ List the main adverse effects that may be encountered and make recommendations for managing them.

♦ List the types of serious adverse event that should be reported without delay on a Serious Adverse Event form. A serious adverse event is defined in the ICH GCP guideline as follows.

Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Accidental overdose should be included.

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