Loeb et al. [I] <12 Median [I] [I] 70% . NS . . NS . NS 12-24 months, 8.1 6864 low, months OR years 26% int, 1.64 (95% CI [D1] 12-24 [D1] (IQR 2% high, 1.32, 2.03), > months, 387 3% NR 24 months [D2] >24 [D2] OR 2.93 [D1] months 347 (95%CI 2.34, 59% 3.68) low, 34% int, 3% high, 4% NR [D2] 47% low, 43% int, 5% high, 4% NR I = immediate treatment group, D = delayed treatment group, NS = not significant, L = low risk disease, In = intermediate risk disease, high = high risk disease. B7) Table Safety of trans-rectal biopsy Study ID Patients Minor Major UTI Urinary Haematuria Others infection infection obstruction Anastasiadis et al. (2015) 198,361 . 1.1% 1.3% 1.4% Hospitalisation 3.7% UK Carignan et al. (2012) Hospitalisation 0.5% 5,798 . 0.8% 0.8% . . Canada Bacteraemia 0.3%
Loeb et al. [I] <12 months, [D1] 12-24 months, [D2] >24 months Median 8.1 years (IQR [I] 6864 [D1] 387 [D2] 347 [I] 70% low, 26% int, 2% high, 3% NR [D1] 59% low, 34% int, 3% high, 4% NR [D2] 47% low, 43% int, 5% high, 4% NR . NS . . NS . NS 12-24 months OR 1.64 (95% CI 1.32, 2.03), > 24 months OR 2.93 (95%CI 2.34, 3.68) I = immediate treatment group, D = delayed treatment group, NS = not significant, L = low risk disease, In = intermediate risk disease, high = high risk disease. B7) Table Safety of trans-rectal biopsy Study ID Patients Minor infection Major infection UTI Urinary obstruction Haematuria Others Anastasiadis et al. (2015) UK 198,361 . 1.1% 1.3% 1.4% Hospitalisation 3.7% Carignan et al. (2012) Canada 5,798 . 0.8% 0.8% . . Hospitalisation 0.5% Bacteraemia 0.3%
1397_Final_MSAC_Assessment_Report.docx