Pharmacokinetic Criteria for Dose Adjustment Sample Clauses

Pharmacokinetic Criteria for Dose Adjustment. Dose adjustment is not available for subjects in Cohort A receiving 75 mg of CV431 QD. If a patient demonstrates adverse events that trigger the need for stopping, that patient will be stopped and an additional patient will be started on the same dose unless the study data indicates a problem with the dose level as recommended by the DSMB. Subjects in Cohort C, receiving 225 mg of CRV431 QD, experiencing a drug exposure related Grade 3,4 or 5 CTCAE can have a dosage reduction to 150 mg of CRV431 once daily.
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