Table 8.3.2.1 Incidence of Premature
Termination Due to Specific Adverse Events in Protocols 203 and 205 |
||
Reason |
Bupropion
Sustained-Release (N=693) |
Placebo (N=235) |
Allergic
(including rash, pruritus, urticaria) |
2.6% |
0.9% |
Headache |
1.3% |
0.9% |
Nausea/Vomiting |
.2% |
0.4% |
Anxiety/Nervousness/Panic
Attack |
0.9% |
0.0% |
Cardiac
(including palpitations, tachycardia, hypertension, chest pain, myocardial
infarction) |
0.7% |
0.9% |
Insomnia |
0.6% |
0.4% |
Agitation |
0.6% |
0.4% |
Dizziness |
0.3% |
0.0% |
Hallucinations |
0.3% |
0.0% |
The
following table lists all those categories of adverse experiences leading to
dropout that were associated with at lest 0.3% of the 3100 subjects who received
bupropion sustained-release in protocol 208.
Table 8.3.2.2 Incidence of Premature
Termination Due to Specific Adverse Events in Protocol 208 |
|
Reason
|
Bupropion
Sustained-Release (N-3167) |
Allergic
(including rash, pruritus, urticaria) |
1.4% |
Headache |
1.1% |
Nausea/Vomiting |
1.1% |
Anxiety/Nervousness/Panic
Attack |
1.5% |
Cardiac
(including palpitations, tachycardia, hypertension, chest pain, myocardial
infarction) |
0.5% |
Insomnia |
1.0% |
Agitation |
0.7% |
Dizziness |
0.5% |
Irritability |
0.5% |
Somnolence |
0.4% |
Impotence |
0.3% (of 1167 males) |
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