Table 6

Study 205: Mean (X) and Mean Change (∆) from Baseline in CGI-S

LAST OBSERVATION CARRIED FORWARD ANALYSIS

Treatment Week:

Baseline

Wk 1

Wk 2

Wk 3

Wk 4

Wk 5

Wk 6

Wk 7

Wk 8

Treatment Groups

N

X

N

N

N

N

N

N

N

N

BUP SR 100 (VL)

112

4.5

106

-0.3

112

-0.6

112

-0.9

112

-1.1

112

-.2

112

-1.4

112

-1.5

112

-1.5

BUP SR 200 (L)

114

4.4

106

-0.3

114

-0.5

114

-0.8

114

-1.0

114

-1.1

114

-1.2

114

-1.3

114

-1.3

BUP SR 300 (M)

110

4.6

105

-0.4

110

-0.7

110

-0.8

111

-1.0

111

-1.2

111

-1.2

111

-1.4

111

-1.4

BUP SR 400 (II)

111

4.6

107

-0.2

111

-0.4

111

-0.8

111

-1.0

111

-1.1

111

-1.1

111

-1.2

111

-1.3

Placebo (P)

116

4.4

109

-0.2

116

-0.5

116

-0.7

116

-0.9

116

-1.0

116

-1.0

116

-1.1

116

-1.2

VL. vs P

2-sided

p-values

for

pairwise

compar-

isons

> 0.2

0.8

0.4

0.05

0.1

0.06

0.03

0.04

0.05

L vs. P

> 0.5

0.4

0.8

0.4

0.4

0.4

0.2

0.3

0.4

M vs. P

< 0.02

0.1

0.2

0.3

0.5

0.3

0.3

0.3

0.4

II vs. P

< 0.05

1.0

0.4

0.4

0.4

0.5

0.6

0.7

0.4

OBSERVED CASES ANALYSIS

Treatment Week:

Baseline

Wk 1

Wk 2

Wk 3

Wk 4

Wk 5

Wk 6

Wk 7

Wk 8

Treatment Groups

N

X

N

N

N

N

N

N

N

N

BUP SR 100 (VL)

112

4.5

106

-.03

103

-0.6

102

-1.0

89

-1.1

85

-1.4

86

-1.7

82

-1.8

76

-1.8

BUP SR 200 (L)

114

4.4

106

-0.3

100

-0.5

95

-0.8

90

-1.1

85

-1.2

83

-1.4

80

-1.6

74

-1.5

BUP SR 300 (M)

111

4.6

105

-0.4

98

-0.7

81

-1.0

80

-1.2

77

-1.5

71

-1.7

69

-1.9

66

-1.9

BUP SR 400 (II)

111

4.6

107

-0.2

94

-0.5

88

-0.9

83

-1.2

77

-1.4

75

-1.5

72

-1.7

70

-1.8

Placebo (P)

116

4.4

109

-0.2

107

-0.5

102

-0.7

90

-1.1

87

-1.2

83

-1.3

82

-1.4

75

-1.5

VL. vs P

2-sided

p-values

for

pairwise

compar-

isons

> 0.2

0.8

02

0.04

0.5

0.1

0.07

0.06

0.2

L vs. P

> 0.5

0.4

1.0

0.4

0.7

0.7

0.4

0.3

0.9

M vs. P

< 0.02

0.1

0.1

0.04

0.3

0.08

0.06

0.3

0.1

II vs. P

< 0.05

1.0

0.9

0.2

0.3

0.2

0.3

0.2

0.1

 

 

Bupropion Sustained-Release Clinical Review                               58

 

 

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

Hosted by www.Geocities.ws

1