PPT Slide
Study Details
- 3 protocol amendments were accepted by FDA to make study more flexible for patients; did not change study endpoints
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- Double-blinded, double dummy
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- Total randomized patients = 2288
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- Less than 35% non-evaluable rate (Protocol allowed for 35%; typical for this type of study)
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- ᢒ% of venograms acceptable to date
PROTECT-1 Phase III Overview