Elevated white blood cell counts

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Reference no: EM134036949

Question

Subject 311 has had elevated white blood cell (WBC) counts for the past two (2) study visits, with no clinical signs or symptoms. "Increased WBC count" is not listed in the Investigator's Brochure (IB) as an adverse event. The investigator should: Immediately fax a handwritten SAE report to the FDA. Hospitalize subject for transfusion Report the elevated WBC to the sponsor as an unexpected adverse event Repeat the laboratory tests until they return to normal before reporting.

Reference no: EM134036949

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