31 A new parameter, firstly studied by Dank et al, ie, the time to therapeutic failure (corresponding to the time between randomization and progression, treatment discontinuation, recurrence, or death) was significantly improved in the FOL-FIRI arm compared with epirubicin + cisplatin + capecitabine (5 months vs 4 months, HR: 0.77, CI: 95% 0.63 0.94; P = 0.008).
Recurrence-free survival (RFS) was defined as the time between randomization and appearance of local or regional recurrence, metastases or death from any cause, whichever came first [ 20].
Most patients, 824 (72.3%), did not have a symptomatic recurrent MI between randomization and the onset of HF.
Relapse-free survival (RFS) was defined as the interval between randomization and the earliest subsequent breast cancer event (all local or systemic recurrences, there were no new breast primaries recorded in this data set).
Fig. 1 Time between randomization and early VAP onset.
The primary outcome was the duration of MV weaning, defined as the time between randomization and a successful extubation.
The screening/baseline assessment will take place within the 3 weeks prior to randomization, randomization will be done between 4 and 8 weeks after surgery and the maximum time between randomization and treatment start will be 15 days.
For subjects who are excluded between randomization and procedure the following information will be collected and reported to the US Food and Drug Administration: reason for dropout, randomization assignment, and baseline data.
Survival is defined as the interval between randomization and death of any cause.
Primary outcome measure is the total number of severe preoperative complications between randomization and exploratory laparotomy.
