Evaluation and registration of adverse events in clinical drug trials in migraine

P. Tfelt-Hansen, N.H. Bjarnason, C. Dahlof, S. Derry, E. Loder, H. Massiou

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

17 Citationer (Scopus)

Abstract

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
Udgivelsesdato: 2008/7
OriginalsprogEngelsk
TidsskriftCephalalgia
Vol/bind28
Udgave nummer7
Sider (fra-til)683-688
Antal sider5
ISSN0333-1024
StatusUdgivet - 2008

Bibliografisk note

Times Cited: 0ReviewEnglishTfelt-Hansen, PUniv Copenhagen, Dept Neurol, Danish Headache Ctr, Glostrup Hosp, Copenhagen, DenmarkCited References Count: 24310NVBLACKWELL PUBLISHING9600 GARSINGTON RD, OXFORD OX4 2DQ, OXON, ENGLANDOXFORD

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