Appendix 7.2.1.3 Efficacy Data for Study 203
|
Table 1 Study 203 Demographic Profile of
Primary Study Sample (N=353)* |
||||||||
|
|
Age (Years) |
Gender |
Race |
Mass (kg) |
||||
|
Treatment Group |
Mean |
Range |
Male N (%) |
Female N (%) |
White N (%) |
Non-White N (%) |
Mean |
Range |
|
Bupropion
Sustained-Release 150 mg/d |
28 |
19-72 |
34 (28%) |
86 (72%) |
100 (83%) |
20 (17%) |
77.2 |
44.0-121.5 |
|
Bupropion
Sustained-Release 300 mg/d |
39 |
18-64 |
24 (21%) |
92 (79%) |
100 (86%) |
16 (14%) |
75.4 |
44.0-133.3 |
|
Placebo |
40 |
19-69 |
48 (41%) |
69 (59%) |
100 (85%) |
17 (15%) |
78.8 |
47.6-147.8 |
*The
sponsor excluded nine of the 362 patients randomly assigned to a treatment
condition at baseline from this table because no treatment phase
assessments
were available.
|
Table 2 Study 203 Patient Completion Rates |
||||||||||
|
Treatment Group |
Number Randomized |
Intent-to- Treat Sample |
Completers at Week [N (%)] |
|||||||
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
|||
|
BUP SR 150 |
121 |
113 |
113 (100%) |
109 (96%) |
98 (87%) |
89 (79%) |
83 (73%) |
70 (62%) |
67 (59%) |
64 (57%) |
|
BUP SR 300 |
120 |
113 |
113 (100%) |
100 (88%) |
98 (87%) |
87 (77%) |
77 (68%) |
74 (65%) |
69 (61%) |
62 (55%) |
|
Placebo |
121 |
116 |
116 (100%) |
112 (97%) |
102 (88%) |
91 (78%) |
75 (65%) |
69 (59%) |
64 (55%) |
56 (48%) |
Bupropion
Sustained-Release Clinical Review 48
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