Patient Discontinuation Criteria Sample Clauses

Patient Discontinuation Criteria. Discontinuation refers to a patient’s stopping administration of study drug. Reasons for study drug discontinuation may include the following: • Confirmed clinical worsening event • Occurrence of an AE or change in medical status that leads the investigator to be concerned about the patient’s welfare • Administrative reasons (e.g., inability to continue) • Sponsor termination of the studyVoluntary withdrawal • Females who become pregnant during the study • Investigator unblinding Patients must discontinue study drug if any of the following occur. • ALT or AST > 8X ULN; • ALT or AST > 5X ULN for 14 days; • ALT or AST > 3X ULN and (total bilirubin > 2X ULN or INR > 1.5); • ALT or AST > 3X ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%); Patients who are discontinued from study drug should still continue in the study, completing all study visits and undergo all scheduled study assessments, if possible.
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