Table Image from Scientific Research

Enumeration of the adverse events reported in the clinical trial over the 1 year after dosing (IP, investigational product). No serious adverse events were observed. The patient experienced transient, asymptomatic neutropenia noted at 6 days after dosing. This resolved without intervention by day 13 after dosing. There was a prolonged episode of abdominal symptoms that included emesis, diarrhea, vomiting and abdominal pain. This episode prompted extensive evaluation, with the ultimate conclusion that the symptoms were due to side effects of tacrolimus plus C. difficile (C-diff) infection.

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