Appendix 8.5.2.1
Criteria for Identifying
Patients with Potentially Clinically Significant Changes in Clinical
Chemistry Variables
Chemistry Test |
Gender |
Ages |
Low |
High |
Total
Bilirubin |
M/F |
All |
<0.12 mg/dL |
>2.0 mg/dL |
Alkaline
Phosphatase |
M |
15-19 |
-- |
>500 U/L |
F |
-- |
>200 U/L |
||
M/F |
20-58 |
-- |
>200 U/L |
|
M/F |
≥59 yrs |
-- |
>230 U/L |
|
ALT
(SGPT) |
M |
≤68 yrs |
-- |
>86 U/L |
F |
-- |
>68 U/L |
||
M |
≥69 yrs |
-- |
>70 U/L |
|
F |
-- |
>64 U/L |
||
AST
(SGOT) |
M |
All |
-- |
>72 U/L |
F |
-- |
>68 U/L |
||
Creatinine |
M |
All |
<0.6 mg/dL |
>1.9 mg/dL |
F |
<0.6 mg/dL |
>1.7 mg/dL |
||
Glucose |
M/F |
<59 yrs |
<56 mg/dL |
>172 mg/dL |
M/F |
≥59 yrs |
<56 mg/DL |
>180 mg/dL |
|
Albumin |
M/F |
<69 yrs |
<2.6 g/dL |
>5.9 g/dL |
M/F |
≥69 yrs |
<2.8 g/dL |
>5.5 g/dL |
|
Sodium |
M/F |
<59 yrs |
<125 mEq/L |
>154 mEq/L |
|
M/F |
≥59 yrs |
<128 mEq/L |
>152 mEq/L |
Potassium |
M/F |
All |
<3.1 mEq/L |
>5.7 mEq/L |
Bicarbonate |
M/F |
All |
<18.6 mEq/L |
>37.7 mEq/L |
Bupropion
Sustained-Release Clinical Review 61
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