Table 8.5.2.2.2 Wilcoxon Rank Sum Analysis of Clinical Chemistry Change Scores in Protocols 203 and 205
Hematology 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
Hemoglobin (↑)	+					+
MCV
Platelets
WBC
Neutrophils (↑)	+	+				+
Lymphocytes (↓)	+	+			*	+
Monocytes (↑)`					+	+
Eosinophils
Basophils

 

 

8.5.2.3                  Urinalysis

 

The sponsor considered dipstick urinalysis blood or protein values of greater than two 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.

 

Table 8.5.2.3 Proportions of Patients Having Potentially Clinically Significant Changes in Urinalysis Variables in Placebo- Controlled Studies 203 and 205
Urinalysis Findings	Bupropion sustained-release			Placebo
	Total Patients	Abnormal		Total Patients	Abnormal
	#	#	%	#	#	%
Hematuria	691	12	1.7%	235	2	0.9%
Proteinuria	693	0	0%	234	1	0.4%

 

The low incidence of hematuria that was observed overall in this study pool made the power to detect a one percentage point statistically significant difference between the observed incidence of hematuria in drug versus placebo-treated patients less than 20 per cent.  Although a Fisher Exact Test comparing the incidence of hematuria in drug-treated vs. placebo-treated group does not reach statistical significance (p=0.54) the

 

 

Bupropion Sustained-Release Clinical Review               36

 

 

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