Clinical signs or symptoms

Reference no: EM133724549

Question

Subject 311 has had elevated white blood cell (WBC) counts for the past two 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: Repeat the laboratory tests until they return to normal before reporting Immediately fax a handwritten SAE report to the FDA. Report the elevated WBC to the sponsor as an unexpected adverse event Hospitalize subject for transfusion.

Reference no: EM133724549

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