URINARY BLADDER:

MOUSE TUMOR TYPE   DOSE (MG/KG/DAY) DOSE (MG/KG/DAY) DOSE (MG/KG/DAY)  
  SEX 0 25 50 Historical Incidence
transitional cell carcinomas M 0/50 0/50 2/50  
    0% 0% 4% 0%
  F 0/50 8/50* 21/48*  
    0% 16% 44% 0%
* = p < 0.5, Fisher's Exact Test. The Fisher's Exact Test was not performed in males due to an insufficient number of males in the control group.

Examination of mice bladders in the trial which was not randomized and in which more than half the male mice in the control group died before the end of the trial demonstrated a significant number of transitional cell carcinomas in female mice.

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