Enclosure 4

 

NDA 20-358

WELLBUTRIN SR (bupropion hydrochloride) Tablets

 

Table 3

Summary of Significance Levels1 (2-sided) for Pairwise

Comparisons (Bupropion SR vs Placebo) in Study 212

Key

Outcome

Variables

150 mg vs Pbo

300 mg vs Pbo

Week2

Week

1

2

3

4

5

6

7

8

1

2

3

4

5

6

7

8

HAMD-17

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

              LOCF

t

-

-

-

-

**

**

**

-

**

-

-

-

-

-

-

              OC

t -

-

-

-

-

-

t

t

-

**

-

t

-

-

-

t

HAMD-28

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

              LOCF

t

t

-

-

-

**

**

**

-

-

-

-

-

-

-

-

              OC

t

t

-

-

-

-

t

*

-

-

-

t

-

-

-

t

HAMD Item 1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

              LOCF

-

-

-

-

-

-

t

t

-

-

-

-

-

-

-

-

              OC

-

-

-

-

-

-

-

-

 

-

-

*

-

-

-

-

CGI Severity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

              LOCF

*

-

-

-

-

-

-

*

-

t

-

t

-

-

-

-

              OC

*

-

-

-

-

-

-

-

-

*

-

*

-

-

-

t

CGI Improvement

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

              LOCF

-

-

-

-

-

*

*

**

**

**

-

-

-

-

-

-

              OC

-

-

-

-

-

-

-

t

**

t

-

*

-

-

-

t

 

1

*

=

p

≤

0.05

 

t

=

p

≤

0.10

 

-

=

p

>

0.10

 

**

=

p

≥

0.025 (criterion p-value for Dunnett’s Test (Original symbol shaded *.  Changed for purpose of re-entering this document.)

 

 

 

 

 

 

2

End of weeks 1-8

 

 

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