Studies 437 and 438 Integrated 0-48 Weeks Grade 3-4 Laboratory Abnormalitiesa

PLB ADV 10

(n=228) (n=294)

ALT (> 5 x ULN) 41% 20%

AST (> 5 x ULN) 23% 8%

Hematuria (? 3+) 10% 11%

CK (> 4 x ULN) 7% 7%

Amylase (> 2 x ULN) 4% 4%

Glycosuria (? 3+) 3% 1%

aObserved in ? 1% of ADV treated patients

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