Table
AD3 Study 212 Mean
(X) and Mean Change (∆) from Baseline in 21-item HAMD |
||||||||||||||||||||
LAST OBSERVATION CARRIED
FORWARD ANALYSIS |
||||||||||||||||||||
Treatment Groups |
Treatment Week |
|||||||||||||||||||
Baseline |
Wk 1 |
Wk 2 |
Wk 3 |
Wk 4 |
Wk 5 |
Wk 6 |
Wk 7 |
Wk 8 |
||||||||||||
N |
X |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
|||
BUP SR 150 (L) |
146 |
24.2 |
145 |
-4.3 |
146 |
-6.8 |
146 |
-8.5 |
146 |
-9.7 |
146 |
-10.3 |
146 |
-11.8 |
146 |
-12.2 |
146 |
-12.1 |
||
BUP SR 300 (II) |
144 |
24.4 |
144 |
-3.1 |
144 |
-4.1 |
144 |
-6.9 |
144 |
-9.1 |
144 |
-9.7 |
144 |
-10.0 |
144 |
-10.8 |
144 |
-11.1 |
||
Placebo (P) |
148 |
23.9 |
145 |
-3.4 |
148 |
-5.9 |
148 |
-8.0 |
148 |
-8.6 |
148 |
-9.6 |
148 |
-9.8 |
148 |
-9.9 |
148 |
-9.8 |
||
2-sided p-values for
pairwise comparisons |
||||||||||||||||||||
L vs P |
> 0.2 |
0.08 |
0.20 |
0.45 |
0.15 |
0.40 |
0.02 |
0.01 |
0.02 |
|||||||||||
II vs P |
> 0.1 |
0.52 |
0.004 |
0.14 |
0.33 |
0.91 |
0.86 |
0.36 |
0.16 |
|||||||||||
OBSERVED CASES ANALYSIS |
||||||||||||||||||||
Treatment Groups |
Treatment Week |
|||||||||||||||||||
Baseline |
Wk 1 |
Wk 2 |
Wk 3 |
Wk 4 |
Wk 5 |
Wk 6 |
Wk 7 |
Wk 8 |
||||||||||||
N |
X |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
|||
BUP SR 150 (L) |
146 |
24.2 |
145 |
-4.3 |
136 |
-6.9 |
133 |
-8.6 |
133 |
-10.1 |
122 |
-10.8 |
118 |
-12.8 |
117 |
-13.6 |
110 |
-13.7 |
||
BUP SR 300 (II) |
144 |
24.4 |
144 |
-3.1 |
136 |
-4.3 |
131 |
-7.6 |
121 |
-10.6 |
111 |
-11.3 |
104 |
-11.8 |
104 |
-13.1 |
101 |
-13.4 |
||
Placebo (P) |
148 |
23.9 |
145 |
-3.4 |
140 |
-6.0 |
132 |
-8.3 |
124 |
-9.2 |
117 |
-10.5 |
114 |
-11.2 |
107 |
-11.7 |
100 |
-11.6 |
||
2-sided p-values for pairwise
comparisons |
||||||||||||||||||||
L vs P |
> 0.2 |
.08 |
0.18 |
0l77 |
0.34 |
0.77 |
0.14 |
0.10 |
0.06 |
|||||||||||
II vs P |
> 0.1 |
0.52 |
0.006 |
0.29 |
0.09 |
0.49 |
0.66 |
0.22 |
0.10 |
|||||||||||
Bupropion SR Clinical Review Addendum for Protocol
212 18
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