uring the three year PROactive clinical trial, 00 patients out of 0000 (0.00%) randomized to pioglitazone hydrochloride and 0 out of 0000 (0.00%) randomized to placebo were diagnosed with bladder cancer. After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 0 (0.00%) cases on pioglitazone hydrochloride and two (0.00%) cases on placebo. After completion of the trial, a large subset of patients was observed for up to 00 additional years, with little additional exposure to pioglitazone hydrochloride. During the 00 years of both PROactive and observational follow-up, the occurrence of bladder cancer did not differ between patients randomized to pioglitazone hydrochloride or placebo (HR =0.00; 