Neutrophil Count Laboratory Abnormality Sample Clauses

Neutrophil Count Laboratory Abnormality. There will be evaluation of the neutrophil counts and WBC performed by an independent Medical Monitor in order to reduce the risk of breaking the blind. Investigators, the study staff, the CRO, and the Sponsor’s study team will not receive absolute and relative neutrophil or WBC count results. Absolute and relative neutrophil and WBC count results will only be disclosed to the respective investigators if ANC < LLN in which case immediate actions will be taken, as described in Figure 2. Retest results will be communicated to investigators who will follow up on neutrophil count and the incidence of infections in subjects having ANC results <1.0 x 109/L. Neutrophil count will be followed until resolution. Dose interruption of study treatment must be undertaken for confirmed ANC results <1.0 x 109/L. The investigator must notify the Sponsor’s Medical Monitor (or designee) within 48 hours of dose interruption. Once the ANC result is above the LLN, subjects may re-initiate blinded study treatment by reducing the study treatment dose to 2 tablets QD (regardless of treatment group) with approval from the Sponsor’s Medical Monitor (or designee). Subjects may be requested to attend an unscheduled visit after dose reduction to collect blood samples for safety and plasma concentrations, if possible. For subjects who have already experienced a dose reduction: If a subject experiences another case of ANC results <1.0 x 109/L, they must permanently discontinue study treatment (refer to Section 7.1).
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