|
Table
AD8.3.1 Reason
for Premature Discontinuation from Protocol 212 |
||||
|
|
Bupropion
Sustained-Release Dosage Group |
|||
|
Bupropion SR (N=302) |
Placebo (N=154) |
|||
|
# |
% of N |
# |
% of N |
|
|
Inadequate Response/ Condition Deteriorated |
16 |
5.3% |
12 |
7.8% |
|
Adverse Experience |
24 |
7.9% |
8 |
5.2% |
|
Lost to Follow-up/Other |
3 |
1.0% |
6 |
3.9% |
|
Consent Withdrawn |
24 |
7.9% |
12 |
7.8% |
|
Protocol Violation |
13 |
4.3% |
9 |
5.8% |
|
Total |
80 |
26.5% |
47 |
30.5% |
AD8.3.2 Adverse
Events Associated with Dropout
As noted in Table AD8.3.1, 7.9% of the bupropion
sustained-release-assigned patients in study 212 withdrew because of an adverse
experience, as compared with 5.2% of placebo-assigned patients.
The following table lists all those categories of
adverse experiences leading to dropout that were associated with at least 2 of
the 302 subjects who were randomly assigned to receive bupropion
sustained-release in protocol 212 who received some of the medication. Incidences for the categories listed for
protocols 203 and 205 and also included.
Placebo rates for the same adverse experiences are shown for
comparison. In those cases where the
individuals 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.
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