Efficacy, safety and tolerability of escitalopram in doses up to 50 mg in Major Depressive Disorder (MDD): an open-label, pilot study

Table 7 Number (%) of patients reporting an adverse event, safety population

Category of AE	n = 60
Any adverse events (AEs)	60 (100)
Treatment-related AEs
Possibly treatment-related	32 (53.3)
Probably treatment-related	16 (26.7)
Definitely treatment-related	0 (0)
Serious AEs	2 (3.3)
Serious treatment-related AEs ^a	0 (0)
Discontinuations due to AEs ^b	12 (20.0)
Treatment-related discontinuations due to AE ^a	10 (16.7)

^a Number (%) of patients with an AE assessed as possibly, probably or definitely related to study medication
^b The AE case report form (CRF) page captured information regarding whether a patient withdrew from the study as a result of an AE. The End of Study CRF page captured withdrawal information and stated that a patient withdrew due to an AE, although this was not recorded as a withdrawal as a result of an AE on the AE CRF page

ISSN: 1471-244X