Sandbox/v29: Difference between revisions
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Gerald Chi (talk | contribs) Created page with " {| style="border: 2px solid #696969;" align="center" |+ <SMALL>''Hy’s Law cases have the following three components:'' | style="background: #A5B2D6; border: 0px solid #6..." |
Gerald Chi (talk | contribs) mNo edit summary |
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{| style="border: 2px solid #696969;" align="center" | {| style="border: 2px solid #696969;" align="center" | ||
|+ | |+ '''Hy’s Law cases have the following three components:''' | ||
| style="font-size: 90%; padding: 1px 1px; background: #F5F5F5; width: 5px" align=left | '''1.''' || style="font-size: 90%; padding: 5px 5px; background: #DCDCDC; width: 620px;" align=left | '''The drug causes hepatocellular injury, generally shown by a higher incidence of <u>≥3xULN of ALT or AST</u> than the (nonhepatotoxic) control drug or placebo.''' | |||
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| style="font-size: 90%; padding: | | style="font-size: 90%; padding: 1px 1px; background: #F5F5F5" align=left | '''2.''' || style="font-size: 90%; padding: 5px 5px; background: #DCDCDC; width: 620px;" | '''Among trial subjects showing such AT elevations, often with ATs much greater than 3xULN, one or more also show <u>elevation of serum TBL to >2xULN</u>, without initial findings of cholestasis (elevated serum ALP).''' | ||
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| style="font-size: 90%; padding: | | style="font-size: 90%; padding: 1px 1px; background: #F5F5F5" align=left | '''3.''' || style="font-size: 90%; padding: 5px 5px; background: #DCDCDC; width: 620px;" | '''No other reason can be found to explain the combination of increased AT and TBL, such as viral hepatitis A, B, or C; preexisting or acute liver disease; or another drug capable of causing the observed injury.''' | ||
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Latest revision as of 19:12, 5 February 2014
1. | The drug causes hepatocellular injury, generally shown by a higher incidence of ≥3xULN of ALT or AST than the (nonhepatotoxic) control drug or placebo. |
2. | Among trial subjects showing such AT elevations, often with ATs much greater than 3xULN, one or more also show elevation of serum TBL to >2xULN, without initial findings of cholestasis (elevated serum ALP). |
3. | No other reason can be found to explain the combination of increased AT and TBL, such as viral hepatitis A, B, or C; preexisting or acute liver disease; or another drug capable of causing the observed injury. |