Results
death
EVENTS
The first patient was randomised in December 2011 but a month later, the study had to be put on temporary hold due to the worldwide shortage of PLD. Patient’s accrual recommenced on 29 November 2013 and by 18 September 2017, 617 patients (306 patients in the carboplatin/PLD and 311 in the trabectedin/PLD group) were randomised from 117 European centres.A planned futility analysis of the primary endpoint (OS) was done after ~100 events in March 2017. The planned second interim analysis to test superiority was done in September 2018 after two-thirds of the death events, with the significance determined by the observed number of events and alpha spending function defined by the O’Brien-Fleming boundary. In both analyses, the trial was not stopped early for futility or efficacy.Six patients were excluded for major violations and 611 were included in the ITT population. Figure 