Predicting potential liver toxicity from phase 2 data: a case study with ximelagatran.

Harry Southworth

Statistics in medicine 2014 Jul 30

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Ximelagatran was denied marketing approval in the USA and was withdrawn from those markets in which it had been approved, because of concerns over potential liver toxicity. A retrospective analysis of phase 2 data relating to liver toxicity is performed using the methods of extreme value modelling. The analysis reveals that the phase 2 data were predictive of the phase 3 results and, had the methods been available at the time, such analysis would have provided valuable information relating to the decision to proceed with further development of the compound. Copyright © 2014 John Wiley & Sons, Ltd.

Citation

Harry Southworth. Predicting potential liver toxicity from phase 2 data: a case study with ximelagatran. Statistics in medicine. 2014 Jul 30;33(17):2914-23