Interventions for bradycardia, tachycardia, hypertension and hypotension comprised titration or interruption of study agent, or additional drug therapy.
An interruption of study medication of no more than 14 consecutive days is permissible.
Twenty patients (77%) experienced adverse events leading to dose interruption of study drugs after cycle 1.
Three rofecoxib-treated patients experienced AEs that led to temporary interruption of study medication (Table 4).
Non-attendance in year 2 was mainly due to students not attending the final teaching sessions, having left the course or having taken an interruption of study.
Throughout the study, 45% of patients required a dose reduction of neratinib and/or paclitaxel due to an adverse event and 72% of patients required a temporary interruption of study medication due to an adverse event.
Of the 205 trainees who entered the 3-year programme during 2007 2009, 116 completed successfully and have graduated with an MSc degree (57%), 36 (18%) completed at Diploma level, 26 (13%) completed at Certificate level, 4 (2%) have returned from an interruption of study, and 23 (11%) withdrew early with no award.
The incidence of genital mycotic infections was higher in males and females with canagliflozin compared with placebo (Table 4); these AEs were generally mild to moderate in severity, treated with topical and/or oral antifungal therapies and resolved without interruption of study drug treatment.
29 In addition to ISTH MB, CRNM bleeding events (i.e., nonmajor bleeding that required hospital admission, physician-guided medical or surgical treatment, or that resulted in a change in antithrombotic therapy including prolonged interruption of study drug) were collected, as were TIMI major and GUSTO severe bleeding events.
Reinstatement is the process of returning to the university after an unapproved interruption of studies.
