AI switches and drug holidays were not regarded as premature discontinuation events unless the patient ultimately discontinued their second AI or did not resume AI therapy after a drug holiday.
Discontinuations of therapy due to breast cancer recurrence were not considered premature discontinuation events.
Secondly, our relatively small sample size also meant that we had few discontinuation events.
4. Mortality and discontinuation events occur at the end of a course of therapy.
Discontinuation was only based on medication refill, in no case patient file information lead to further discontinuation events.
Withdrawals due to adverse events were evenly distributed throughout the treatment period, whereas previous studies, in which treatment was initiated at doses of 100 mg per day or higher, most discontinuation events occurred during the first two weeks of treatment.
Among 794 participants, 377 experienced a total of 766 ART discontinuation events (defined as 90 days off ART following previous enrolment), for an incidence density of 27.7 (95%% confidence interval [CI]: 25.1 30.5) per 100 person-years.
However, due to the low number of discontinuation events we are unable to rule out the possibility of a clinically important effect with SSRI treatment as the S allele may be associated with up to a 42% increase in odds of discontinuation or a 17% reduced odds (OR 1.09, 95% CI 0.83 1.42).
A competing risks extension of the Cox time-to-event model was used to further assess for the influence of informative censoring on event ascertainment, for example the influence of differences in follow-up time (censoring at last observed assessment) by treatment arm on observing relapse or discontinuation events.
The rate of serious adverse events, serious adverse events leading to discontinuation and adverse events occurring on treatment were similar in the edoxaban and warfarin groups.
