EXTREME: Incidencia de Toxicidad Grado 3/4
CT* alone (n=215)
Cetuximab + CT* (n=219)
¶
*Platinum-based CT, consisting of cisplatin/carboplatin + 5-FU;
†
Except for
sepsis, included for significant difference between arms, and infusion
reaction, included for its relationship to cetuximab,
‡
p=0.05 vs CT alone;
§
p=0.02 vs CT alone;
¶
p<0.001 vs CT alone:
AEs, adverse events
‡
Vermorken JB, et al. N Engl J Med 2008;359:1116–1127
‡
Grade 3 and 4 AEs with a frequency ≥5%
†
in either arm of the safety population
§
*Platinum-based CT, consisting of cisplatin/carboplati + 5-FU;
†
Except for
sepsis, included for significant difference between arms, and i fusion
reaction, included for its r lati ship to cetuximab,
‡
p=0.05 vs CT alone;
§
p=0.02 vs CT alone;
¶
p<0.001 vs CT alone:
AEs, adverse events