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Rockwell Medical, Inc. Message Board

  • wchenf5 wchenf5 Jun 14, 2013 12:11 PM Flag

    NO, the CRUISE endpoint only requires 0.31 gram change for Efficacy

    Cecause the SFP trial had recruted 300 patients, assuming 80% of patients complete the trial, that is 120 on each arm. Let's further assume that the standard deviation for Hgb remains the same 1.1 - 1.2 as the SFP Phase IIb trial and the Venofer (IV iron) Phase III trial (NCT00236938). With SD = 1.2, and N = 120, you only need 0.31 g/dL for efficacy.

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