Toxicity & dose reductions
fatigue, Toxicities, rash
ADVERSE EVENTS
Dose interruptions and reductions were relatively uncommon. In both arms, patients received a median of 100% of the intended doses of saracatinib or placebo whilst on treatment (mean of 95% doses in saracatinib/AI arm, 99% placebo/AI arm). Nineteen percent in the saracatinib/AI group required a first dose reduction (to 125 mg) compared to 10% in placebo/AI group. A further two patients (3%) had a second dose reduction (to 50 mg) in the saracatinib/AI group, with no further reductions in the placebo/AI group. The most common reasons for dose reduction (saracatinib/AI vs. placebo/AI) were gastrointestinal side effects (8% vs. 3%), rash (3.0% vs. 0%) and fatigue (3.0% vs. 1%).Grade 1–4 adverse events in each treatment arm are reported in Table Comparison of Toxicities in Saracatinib/AI and Placebo/AI