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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