OPTIMAL: summary of safety data1

Image 19@2x.png

Data are n (%) and are for the safety population (all patients who received at least one dose of study drug);
each patient was only counted once even though they might have had several events across different body systems
ALT = alanine aminotransferase; ILD = interstitial lung disease; SAE = serious adverse event
*Increased ALT concentration (n=3), skin rash (n=1), total bilirubin increase (n=1), stomatitis (n=1); one patient had both rash and raised ALT concentration. †Spleen cyst. ‡Two cases of ALT increase. §Decreased platelet count (n=8), decreased neutrophil count (n=1), and hepatic dysfunction (n=1)

Reference

  1. Zhou C, et al. Lancet Oncol 2011; 12:735–42

OPTIMAL: most common adverse events reported in 3% of patients or more in either treatment group 1

Image 20@2x.png

Data are n (%) and are for the safety population (all patients who received at least one dose of study drug); each patient was only counted once even though they might have had several events across different body systems: ALT = alanine aminotransferase

Reference

  1. Zhou C, et al. Lancet Oncol 2011; 12:735–42