Table
AD5 Study 212 Mean
(X) and Mean Change (∆) from HAMD Depressed Mood Item #1 |
||||||||||||||||||||
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 |
2.8 |
145 |
-0.4 |
146 |
-0.7 |
146 |
-0.9 |
146 |
-1.0 |
146 |
-1.2 |
146 |
-1.3 |
146 |
-1.3 |
146 |
-1.4 |
||
BUP SR 300 (II) |
144 |
2.8 |
144 |
-0.3 |
144 |
-0.5 |
144 |
-0.9 |
144 |
-1.1 |
144 |
-1.1 |
144 |
-1.1 |
144 |
-1.3 |
144 |
-1.3 |
||
Placebo (P) |
148 |
2.9 |
145 |
-0.3 |
148 |
-.06 |
148 |
-0.9 |
148 |
-1.0 |
148 |
-1.1 |
148 |
-1.1 |
148 |
-1.1 |
148 |
-1.1 |
||
2-sided p-values for
pairwise comparisons |
||||||||||||||||||||
L vs P |
> 0.6 |
0.46 |
0.48 |
0.61 |
0.59 |
0.50 |
0.14 |
0.07 |
0.10 |
|||||||||||
II vs P |
> 0.4 |
0.57 |
0.28 |
0.99 |
0.12 |
0.98 |
0.53 |
0.26 |
0.29 |
|||||||||||
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 |
2.8 |
145 |
-0.4 |
136 |
-0.7 |
133 |
-1.0 |
133 |
-1.1 |
122 |
-1.3 |
118 |
-1.4 |
117 |
-1.5 |
110 |
-1.6 |
||
BUP SR 300 (II) |
144 |
2.8 |
144 |
-0.3 |
136 |
-0.5 |
131 |
-1.0 |
121 |
-1.3 |
111 |
-1.3 |
104 |
-1.2 |
104 |
-1.5 |
101 |
-1.6 |
||
Placebo (P) |
148 |
2.9 |
145 |
-0.3 |
140 |
-0.6 |
132 |
-0.9 |
124 |
-1.0 |
117 |
-1.2 |
114 |
-1.3 |
107 |
-1.3 |
100 |
-1.4 |
||
2-sided p-values for pairwise
comparisons |
||||||||||||||||||||
L vs P |
> 0.6 |
0.46 |
0.46 |
0.70 |
0.80 |
0.66 |
0.37 |
0.23 |
0.21 |
|||||||||||
II vs P |
> 0.4 |
0.57 |
0.32 |
0.62 |
0.03 |
0.71 |
0.65 |
0.12 |
0.14 |
|||||||||||
Bupropion SR Clinical Review Addendum for Protocol
212 19
Back a Page
Next Page
Back to Wellbutrin SRŪ NDA Index Page
Back to Main
Index