Subjects without documented objective progression at the time of the final analysis were censored at the date of their last tumour assessment.
Patients who had not progressed at the time of the final analysis were censored at the date of their last tumour assessment.
The cut-off date for the final analysis was 15 January 2008.
A total of 64 Japanese patients were enrolled in the study between December 2007 and February 2009 and the last patient's last visit was 9 August 2013 (data cutoff date for the final analysis; Table 1).
Of 5149 women, 60 women had data missing on key variables (e.g., date of birth, date of questionnaires, gene mutation) and were excluded, leaving 5089 women in final analysis.
Of the 7021 women, six had data missing on key variables (for example, date of birth, date of questionnaires, gene mutation) and were excluded, leaving 7015 women in the final analysis.
Only 612 of the female students were included in the final analysis, partly because many of the girls did not report their exact dates of birth or age at menarche.
In those cases, the regulator's tracking was "inaccurate or out of date, key file documentation was missing or the files lacked a final analysis of a company's submissions and reports or a conclusion as to whether the condition had been fully satisfied".
Participants will be made aware via the participant information sheet that should they withdraw, the data collected to date cannot be erased and may still be used in the final analysis.
Patients alive at final analysis or who have become lost to follow up will be censored at their last contact date.
Statistical analyses will be performed using eCRF data collected until a clinical cut-off date that is defined when the number of events required for the interim and final analysis of the efficacy variables will be achieved.
