Study Criteria Sample Clauses

Study Criteria. Dosing of study drug within the study will be stopped and recruitment into the study will be paused until a review of all available safety information is performed by the DSMB, Medical Monitor, and Sponsor if any of the following occur: • ≥3 subjects in the study experience an SAE that is judged to be related to study drug by the investigator and sponsor; • ≥3 subjects in the study experience a Grade 3 or Grade 4 CTCAE AE in the same system organ class (SOC) that are judged to be related to study drug by the investigator and sponsor; • ≥3 subjects in the study experience a Grade 3 or Grade 4 CTCAE laboratory abnormality that are judged to be related to study drug by the investigator and sponsor. Asymptomatic elevations in cholesterol or triglycerides accepted; • ≥3 subjects in the study experience a confirmed: − Friderica’s QT Correction Formula (QTcF) interval ≥500 msec; OR − QTcF interval change from baseline ≥60 msec that has an absolute value ≥ 480 msec; ▪ The value of an individual ECG time point is the average of the triplicate values ▪ “confirmed” is defined as the abnormality duplicated, at least 1 hour after the abnormality is first noted, by the results of a set of 3 ECGs performed in triplicate, at least 5, but not more than 10 minutes between each assessment. • ≥1 subject with AT >3 x ULN or >3 x subject baseline that is confirmed, not initially cholestatic, and judged to be adversely related to study drug (DILI) by the investigator and sponsor.
Sample 1
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Related to Study Criteria

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