Time course of regorafenib-associated adverse events in the phase III CORRECT study
C Denzlinger, A Grothey, AF Sobrero, E van Cutsem, S Siena, A Falcone, M Ychou, Y Humblet, O Bouche, L Mineur, C Barone, A Adenis, J Tabernero, T Yoshino, HJ Lenz, RM Goldberg, F Cihon, A Wagner, D Laurent · Zeitschrift für Gastroenterologie · 2013 · Heft 08
Bibliografische Angaben
Zusammenfassung
Aims: Regorafenib (REG) is an oral multikinase inhibitor that has recently demonstrated significant overall survival benefit vs. placebo in the randomized Phase III CORRECT study. Methods: We examined the time course of adverse events (AEs) in the CORRECT study. Results: The safety population comprised 753 patients (pts): REG n = 500; placebo n = 253. The mean treatment duration was 12.1 ± 9.7 weeks in the REG group and 7.8 ± 5.2 weeks in the placebo group. Treatment-emergent AEs occurred at any grade in 99.6% of REG pts and 96.8% of placebo pts, at grade 1/2 in 21.6% and 47.8%, respectively, at grade 3 in 56.0%…
