So, this study is a prospective randomized study, including patients with high-grade bladder tumor, in particular T1, G3, or carcinoma in situ. And we randomized these patients in two groups. One group is a BCG installation, where six weekly installation is a standard course. And the other group, they receive one daily – there is two different installation – one day for mitomycin, then the day after from of BCG...
So, this study is a prospective randomized study, including patients with high-grade bladder tumor, in particular T1, G3, or carcinoma in situ. And we randomized these patients in two groups. One group is a BCG installation, where six weekly installation is a standard course. And the other group, they receive one daily – there is two different installation – one day for mitomycin, then the day after from of BCG.
So, the study is still ongoing. And here during this congress, we present our preliminary results, particularly focused on the safety of this new possibility. And in the first 20 patients enrolled in the combination treatment we observed no significant and no particular adverse events when compared to the standard group. The rate of adverse events evaluated using the Clavien classification system is very low, and only three patients in both groups experienced a high-grade complication, including a urethral stenosis, or a urinary tract infection, but they are expected and they’re not new.
So, we hope that together with safety next year we are able to present the results on efficacy. And because this a new combination, it could be another option to manage patients with high-grade bladder cancer.