Table 2–
Adverse events by randomization arm where differences are calculated as the difference in the transrectal arm subtracted from the transperineal arm
| Characteristic | Transperineal (N = 287), n (%) | Transrectal (N = 280), n (%) | Difference (%) | 95% Confidence interval (%) | p value |
|---|---|---|---|---|---|
| Infection | 0 (0) | 4 (1.4) | −1.4 | −3.6, 0.2 | 0.059 |
| Urinary retention | 1 (0.3) | 3 (1.1) | −0.7 | −2.8, 1.0 | |
| Bleeding requiring intervention | 0 (0) | 1 (0.4) | −0.4 | −2.0, 1.0 | |
| Gleason grade group 2–5 | 151 (53) | 141 (50) | 2.0 | −6.0, 10 | |
| Gleason grade group 1 | 49 (17) | 62 (22) | −5.1 | −12, 1.7 |
CI = confidence interval.
Values are presented as n (%); differences along with Newcombe hybrid score 95% confidence intervals and p values were calculated using Fisher’s exact test for the primary outcome of infection. For cancer detection outcomes, Gleason grade group differences adjusted for site along with 95% confidence intervals were calculated using the logistic regression least-squares adjusted mean difference (95% CI).