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

 

Back a Page
Next Page
Back to Wellbutrin SRŪ NDA Index Page
Back to Main Index

Hosted by www.Geocities.ws

1