Study design and treatment
ONCOLOGY
The design of the randomized, double-blind, placebo-controlled, phase III TAGS study (NCT02500043; registered on July 16, 2015), which was performed in 110 academic hospitals across 17 countries, has been previously described in detail (Shitara et al. Patients were randomized in a 2:1 ratio (stratified by geographic region, Eastern Cooperative Oncology Group performance status (ECOG PS), and prior RAM treatment) to receive either oral FTD/TPI 35 mg/m