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

Wade et al. BMC Psychiatry 2011 11:42   doi:10.1186/1471-244X-11-42

Open Data