5.1.2
Demographics
Table 5.1.2.1 presents the demographics information for patients studied in Phase I trials. These subjects were all male, predominantly white, and age 40 or under. Table 5.1.2.2 provides the demographic profile for the primary efficacy study population: all patients exposed to bupropion sustained-release or placebo in the clinical efficacy phase 2-3 trials, with the exception of 36 patients for whom no treatment phase assessments were available. Table 5.1.2.3 provides the demographic profile all patients known to have received study medication in the Phase 3 seizure incidence trial. Patients were mainly white females under age 60. Bupropion sustained-release and placebo groups in the integrated efficacy and safety data sets are similar, as the tables illustrate.
|
Table 5.1.2.1 Demographic Profile of
Bupropion sustained-release for Phase 1 Studies (N=132) |
||
|
Parameter |
Value |
|
|
Age
(Years) |
Mean |
25 |
|
Range |
18-40 |
|
|
Gender |
Male |
100% |
|
Female |
0% |
|
|
Race |
White |
73% |
|
Non-White |
27% |
|
|
Mass
(kg) |
Mean |
73.6 |
|
Range |
58.5-88.9 |
|
|
Table 5.1.2.2 Demographic Profile for
Phase 2 and 3 Clinical Efficacy Studies |
|||
|
Parameter |
Bupropion (N=693) |
Placebo (N=235) |
|
|
Age
(Years) |
Mean |
39 |
40 |
|
Range |
18-79 |
19-82 |
|
|
Gender |
Male |
34% |
37% |
|
Female |
66% |
63% |
|
|
Race |
White |
86% |
88% |
|
Non-White |
14% |
12% |
|
|
Mass
(kg) |
Mean |
78.3 |
79.1 |
|
Range |
44.0-167.8 |
47.6-155.1 |
|
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