|
Table 8.5.2.2.1 Proportions of Patients
Having Potentially Clinically Significant Changes in Hematology Variables in Protocols 203 and 205 |
||||||
|
Hematology
Variables |
Bupropion
sustained-release |
Placebo |
||||
|
Total
Patients |
Abnormal |
Total
Patients |
Abnormal |
|||
|
# |
# |
% |
# |
# |
% |
|
|
Hemoglobin
- Low |
693 |
0 |
0% |
235 |
1 |
0.4% |
|
Hemoglobin
– High |
693 |
0 |
0% |
235 |
0 |
0% |
|
MCV
– Low |
691 |
1 |
0.1% |
235 |
1 |
0.4% |
|
MCV
– High |
691 |
0 |
0% |
235 |
0 |
0% |
|
WBC
– Low |
693 |
2 |
0.3% |
235 |
1 |
0.4% |
|
WBC-
High |
692 |
1 |
0.1% |
235 |
0 |
0% |
|
Neutrophils
– High |
693 |
2 |
0.3% |
235 |
0 |
0% |
|
Lymphocytes
– High |
693 |
0 |
0% |
235 |
1 |
0.4% |
|
Monocytes
– High |
693 |
0 |
0% |
235 |
0 |
0% |
|
Eosinophils
– High |
692 |
1 |
0.1% |
235 |
0 |
0% |
|
Basophils
– High |
693 |
0 |
0% |
235 |
0 |
0% |
|
Platelets
– Low |
693 |
0 |
0% |
235 |
1 |
0.4% |
|
Platelets
– High |
693 |
0 |
0% |
235 |
0 |
0% |
The
number of patients exceeding the bounds of normal hematology values was not
large enough to draw any significant statistical inferences about different
effects of drug versus placebo upon these hematology values. Mean changes from baseline to last visit in
serum chemistry parameters were compared by the sponsor across treatment groups
with Wilcoxon rank sum analysis (Table 8.5.2.1.2). Although there were some statistically significant differences,
none were felt to be clinically important.
No patients were discontinued because of hematological findings.
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