Table
AD6 Study 212 Mean
(X) and Mean Change (∆) from Baseline in CGI-S |
||||||||||||||||||||
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 |
4.3 |
145 |
-0.4 |
146 |
-0.7 |
146 |
-0.9 |
146 |
-1.0 |
146 |
-1.2 |
146 |
-1.4 |
146 |
-1.5 |
146 |
-1.5 |
||
BUP SR 300 (II) |
144 |
4.3 |
144 |
-0.3 |
144 |
-0.4 |
144 |
-0.8 |
144 |
-1.1 |
144 |
-1.1 |
144 |
-1.1 |
144 |
-1.3 |
144 |
-1.4 |
||
Placebo (P) |
148 |
4.3 |
145 |
-0.3 |
148 |
-0.6 |
148 |
-0.9 |
148 |
-0.9 |
148 |
-1.1 |
148 |
-1.2 |
148 |
-1.2 |
148 |
-1.2 |
||
2-sided p-values for
pairwise comparisons |
||||||||||||||||||||
L vs P |
> 0.8 |
0.04 |
0.17 |
0.86 |
-.43 |
0.38 |
0.11 |
0.12 |
0.05 |
|||||||||||
II vs P |
> 0.4 |
0.81 |
0.06 |
0.26 |
0.09 |
0.99 |
0.70 |
0.53 |
0.15 |
|||||||||||
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 |
4.3 |
145 |
-0.4 |
136 |
-0.7 |
133 |
-0.9 |
133 |
-1.1 |
122 |
-1.4 |
118 |
-1.6 |
117 |
-1.6 |
110 |
-1.7 |
||
BUP SR 300 (II) |
144 |
4.3 |
144 |
-0.3 |
136 |
-0.4 |
131 |
-0.8 |
121 |
-1.3 |
111 |
-1.3 |
104 |
-1.4 |
104 |
-1.7 |
101 |
-1.8 |
||
Placebo (P) |
148 |
4.3 |
145 |
-0.3 |
140 |
-0.6 |
132 |
-0.9 |
124 |
-1.0 |
117 |
-1.2 |
114 |
-1.4 |
107 |
-1.5 |
100 |
-1.4 |
||
2-sided p-values for
pairwise comparisons |
||||||||||||||||||||
L vs P |
> 0.8 |
0.04 |
0.15 |
0.88 |
0.76 |
0.59 |
0.26 |
0.39 |
0.12 |
|||||||||||
II vs P |
> 0.4 |
0.81 |
0.05 |
0.34 |
0.04 |
0.66 |
0.91 |
0.39 |
0.07 |
|||||||||||
Bupropion SR Clinical Review Addendum for Protocol
212 20
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