OPTIMAL phase III trial

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)

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