|
Table
AD8.3.2 Incidence
of Premature Termination Due to Specific Adverse Events in Protocols 212 |
||
|
Bupropion
Sustained-Release Dosage Group |
||
|
Reason |
Bupropion SR (N=302) |
Placebo (N=154) |
|
Allergic
(including rash, pruritus, urticaria) |
1.0% |
0.0% |
|
Headache |
1.0% |
0.6% |
|
Anxiety/Nervousness/Panic Attack |
1.0% |
0.6% |
|
Lost to Follow-up/Other |
0.7% |
0.0% |
|
Gastroenteritis/Esophagitis |
0.7% |
0.0% |
|
Cardiac (including chest pain) |
.03% |
0.0% |
|
Insomnia |
0.3% |
0.0% |
|
Agitation |
0.0% |
0.0% |
|
Dizziness |
0.0% |
0.0% |
|
Hallucinations |
0.0% |
0.0% |
AD8.4 Safety
Findings Discovered with Other Specific Strategies/Search for Serious Events
The sponsor conducted a manual search of the available clinical data from study for events that it considered “serious.” The criteria for “serious” were fatal, life-threatening, permanently disabling, requiring or prolonging hospitalization, congenital abnormality, overdose, cancer, other – as determined by the investigators. Three such events were identified in study 212. Two of these occurred in subjects who received bupropion sustained-release and one occurred in a subject receiving placebo. Attribution of cause of serious events was left at the discretion of the individual investigators. None of the adverse events was attributed to the medication by the sponsor. In addition patient #40540 (in the 300 mg/d group) experienced a spontaneous abortion eight days after discontinuation from the study for a protocol violation. The patient had a history of two abortions and the investigator rated the adverse experience as not reasonably attributable to the study medication. No patient taking the medication overdosed or attempted suicide during the course of study 212. Although seizure incidence was a major concern with the immediate-release form of bupropion, no patient experienced a seizure during the course of study 212.
All events that the sponsor categorized as serious
that were thought by the sponsor or this reviewer as being possibly or
reasonably attributable to bupropion sustained-release in study 212 are listed
in Appendix AD8.4.
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