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Tolerability of a drug should be regarded as important as its efficacy. In all four phases of drug development evaluation of adverse events is important. Recommendations for assessment of adverse events in acute and prophylactic clinical drug trials in migraine are given. Tolerability may be indirectly assessed using measures of general well-being and eight such tools are presented. Finally, recommendations for reporting of adverse events are given.

Original publication

DOI

10.1111/j.1468-2982.2008.01600.x

Type

Journal article

Journal

Cephalalgia

Publication Date

07/2008

Volume

28

Pages

683 - 688

Keywords

Adverse Drug Reaction Reporting Systems, Analgesics, Cross-Over Studies, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Humans, Migraine Disorders, Randomized Controlled Trials as Topic, Registries