|
Table 8.5.2.1.2 Wilcoxon Rank Sum Analysis
of Clinical Chemistry Change Scores in Protocols 203 and 205 |
||||||
|
Clinical
Chemistry and Direction of Statistically Significant Change |
p values for Treatment vs.
Placebo *= <0.05; + = <0.01 |
|||||
|
Protocol 203 |
Protocol 205 |
|||||
|
150 mg/d |
300 mg/d |
100 mg/d |
200 mg/d |
300 mg/d |
400 mg/d |
|
|
Albumin
(↓) |
|
|
|
|
|
* |
|
Alk.
Phosphatase (↑) |
+ |
|
|
|
* |
* |
|
ALT |
|
|
|
|
|
|
|
AST |
|
|
|
|
|
|
|
Bicarbonate |
|
|
|
|
|
|
|
Bilirubin |
|
|
|
|
|
|
|
Creatinine
(↑) |
+ |
+ |
+ |
+ |
+ |
+ |
|
Glucose
(↓) |
* |
|
|
|
|
|
|
Potassium |
|
|
|
|
|
|
|
Sodium
(↑) |
* |
|
|
|
|
|
8.5.2.2
Hematology
Appendix
8.5.2.2 lists the bounds that the sponsor provided for consideration of abnormal
chemistry values as being of potential clinical significance.
The
following table displays the proportions of patients meeting those criteria in
placebo-controlled trials 203 and 205.
Patients were counted if they exceeded a laboratory value at the point
of discontinuation from the study. The
denominator from which the percentages are calculated is the number of patients
in that dosing group, excluding those who had lab values beyond the bounds
specified before and after the study.
Back a Page
Next Page
Back to Wellbutrin SRŪ NDA Index Page
Back to Main
Index