Adverse events of interferon beta-1a: a prospective multi-centre international ICH-GCP-based CRO-supported external validation study in daily practice.
(2011) PLoS One — Vol. 6, n° 10, p. e26568 (2011)
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- Abstract
- Three out of four RRMS patients treated with IM INFb-1a in daily practice experience treatment-related AEs, most of these being mild. Our data externally validate the favorable phase III safety profile of IM INFb-1a and suggest that the real-life incidence of treatment-related AEs is less than reported in the pivotal phase III trial. Larger studies are needed to detect rare, potentially hazardous AEs of IM INFb-1a.
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Jongen, P. J., Sindic, C., Sanders, E., Hawkins, S., Linssen, W., van Munster, E., Frequin, S., & Borm, G. (2011). Adverse events of interferon beta-1a: a prospective multi-centre international ICH-GCP-based CRO-supported external validation study in daily practice. PLoS One, 6(10), e26568. https://doi.org/10.1371/journal.pone.0026568 (Original work published 2011)