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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