is now available, are included as are about 1740 patients or volunteers¹ not previously reported.  The cut-off date for this update is March 31, 1996.

 

Line listing of all patients and volunteers with serious adverse events and with adverse events leading to premature study discontinuation are presented by study. In addition, narrative summaries are provided for all serious adverse events and for adverse dropouts in Studies 209, 403, and 407, which are completed studies.

 

2. Review of Safety Data

 

Methodology

Listing of all serious adverse events and adverse events leading to dropout were examined to identify any clinically important adverse events which had not been previously observed in association with Wellbutrin immediate-release (based on adverse event listings in Wellbutrin labeling) or with Wellbutrin SR (based on the adverse events listings in the proposed Wellbutrin SR labeling).

 

Serious Adverse Events

Eight serious adverse events, which did not appear to be previously reported, occurred in this database.  These cases are summarized in Table 1 below.

 

Table 1: Serious AE’s Not Previously Reported
Study/Pt. #	Age	Sex	Treatment	Days to Onset	Event
WHITED OUT

 

 

        Under Treatment, WBSR300=Wellbutrin SR 300 mg/day.

        Under Days to Onset, + indicates days post-treatment

 

 

¹This number is approximate since Studies 209, 404, and 405 are still blinded.

 

 

Page 2

 

 

 

 

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