Patients
Between June 17, 2012, and October 8, 2013, a
total of 1002 patients were screened for eligibility,
of whom 800 underwent randomization, with
534 assigned to receive TAS-102 and 266 assigned
to receive placebo (intention-to-treat population)
(details regarding the disposition of
patients are provided in Fig. S1 in the Supplementary
Appendix, available at NEJM.org). Treatment
was initiated in 798 patients, with 533
receiving TAS-102 and 265 receiving placebo
(safety-analysis population). All treated patients
received their assigned study drug according to
the randomization schema, and 760 could be
evaluated for assessment of tumor response
(tumor-response population).