Table 8.3.1.2, supplied by the sponsor, summarizes reasons for premature discontinuation among patients who were assigned to receive treatment under protocol 208.  Because 67 patients assigned to receive treatment dropped out between point of randomization and first ingestion of medication, the total number of subjects in this table is larger by 67 than the number of subjects in the demographics table of section 5.1.2.

 

 

 

8.3.2                       Adverse Events Associated with Dropout

 

As noted in Table 8.3.1, 10.2% of the bupropion sustained-release-assigned patients in the integrated Phase 2-3 safety database withdrew because of an adverse experience, as compared with 5.7% of placebo-assigned patients.

 

The following table lists all those categories of adverse experiences leading to dropout that were associated with at least 0.3% of the 693 subjects who were randomly assigned to receive bupropion sustained-release in protocols 203 and 205 who received some of the medication.  Placebo rates for the same adverse experiences are shown for comparison.  In those cases where the individual investigators did not designate a specific adverse event resulting in discontinuation, this reviewer assigned the specific adverse event or events based on the case report listings or narrative case summaries.

 

 

Bupropion Sustained-Release Clinical Review               26

 

 

 

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