Open AccessEvaluation and registration of adverse events in clinical drug trials in migraine
Author(s) -
TfeltHansen P,
Bjarnason NH,
Dahlöf C,
Derry S,
Loder E,
Massiou H
Publication year - 2008
Publication title -
cephalalgia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.57
H-Index - 125
eISSN - 1468-2982
pISSN - 0333-1024
DOI - 10.1111/j.1468-2982.2008.01600.x
Subject(s) - tolerability , medicine , migraine , adverse effect , clinical trial , drug , drug trial , intensive care medicine , drug development , pharmacology
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.