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During the first 2 weeks of the study, 25 unscheduled deaths occurred in the
700 mg/kg/day toxicity and toxicokinetic groups. Twelve animals were sacrificed for
general debilitation and the remaining animals were found dead. Clinical signs observed
included hypoactivity, squinted eyes, hunched, rough haircoat, cold to the touch, and/or
irregular respiration. No macroscopic evidence of gavage errors were found at necropsy.
These animals were replaced during this initial period. Three more unscheduled deaths
occurred in the female toxicokinetic groups, one at 500 mg/kg/day and two at
700 mg/kg/day; however, no replacement females were available. These deaths were
considered BI 201335 NA-related based upon the adverse clinical signs and high
incidence at 700 mg/kg/day.
After the initial 2 weeks of the study, 7 more unscheduled deaths occurred in the toxicity
groups: two 700 mg/kg/day females, two 700 mg/kg/day males, two 300 mg/kg/day
females, and one 70 mg/kg/day female. Microscopic findings suggest that gavage trauma
caused three of the unscheduled deaths: one 700 mg/kg/day male, one 300 mg/kg/day
female, and one 700 mg/kg/day female. The causes of death/moribund sacrifice and any
association with test article administration in the others were undetermined.
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FROM 60.183.7.*