Appendix 8.5.3.2
Number and Percentage of
Patients with Abnormal Vital Signs at Any Point after Treatment Commenced in
Protocols 203 and 205
|
Placebo-Treated |
Bupropion sustained- release-Treated 100-200 mg/d |
Bupropion
sustained-release Treated 300-400 mg/d |
All Bupropion
sustained-release-Treated |
|||||
Exposed
to Treatment: |
Total N=231 |
Total N=346 |
Total N=344 |
Total N=680 |
|||||
|
Number with abnormality |
% of N |
Number with abnormality |
% of N |
Number with abnormality |
% of N |
Number with abnormality |
% of N |
P value compared with Placebo |
Systolic or Diastolic Hypertension (systolic
≥ 180 mm Hg with
increase ≥ 20, or Diastolic
≥ 150 mm Hg with increase ≥15)* |
2 |
0.9% |
1 |
0.3% |
2 |
0.6% |
3 |
0.4% |
Fisher p-0.61 |
Systolic or Diastolic Hypertension (systolic
≤90 mm Hg with
decrease ≥ 20, or Diastolic
≤ 50mm Hg with increase ≥15)* |
5 |
2.2% |
10 |
2.9% |
9 |
2.7% |
19 |
2.8% |
Yates p=0.78 |
Tachycardia >120 bpm with increase ≥15)* |
0 |
0.0% |
1 |
0.3% |
1 |
0.3% |
2 |
0.3% |
Fisher p=1.0 |
Bradycardia (<50 bpm with decrease ≥15)* |
0 |
0.0 |
3 |
0.9% |
0 |
0.0% |
3 |
0.4% |
Fisher p=0.58 |
Weight
Gain ≥ 5 lbs)* |
27 |
11.7% |
30 |
8.7% |
23 |
6.9% |
53 |
7.8% |
Yates p=0.094 |
Weight
Loss (≥ 5 lbs)* |
33 |
14.3% |
71 |
20.5% |
111 |
33.2% |
182 |
26.8% |
Yates p=<0.001 |
*All
changes were calculated relative to baseline assessment (Day 0)
Bupropion
Sustained-Release Clinical Review 63
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