Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
6016768 | European Journal of Paediatric Neurology | 2013 | 8 Pages |
Abstract
The study results concerning non-inferiority were not conclusive, as the calculated sample size was not reached to support sufficient statistical power due to limited recruitment in a 26 months period. The rates of seizure free patients were [relatively] high in both groups. However, the results indicate that termination of drug treatment due to seizure recurrence or adverse events occurred more frequently in the LEV group compared to STM. Behavioral disturbances were the most common adverse event causing study termination.
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Authors
Ingo Borggraefe, Michaela Bonfert, Thomas Bast, Bernd Axel Neubauer, Klaus Juergen Schotten, Kai MaÃmann, Soheyl Noachtar, Ingrid Tuxhorn, Theodor W. May, Florian Heinen, German HEAD Study Group German HEAD Study Group,