Table 3 Predefined adverse events

Expected adverse events after biopsy:

 ➢ Hematospermia

 ➢ Hematuria > 2 days

 ➢ Rectal bleeding > 2 days

 ➢ Symptomatic prostatitis

 ➢ Symptomatic cystitis

 ➢ Symptomatic epididymitis

 ➢ Rectal abscess

 ➢ Urinary retention

 ➢ Chills in combination with fever > 38.5 °C

 ➢ Fever > 38.5 °C

Expected serious adverse events include:

 ➢ Hematuria with urinary bladder tamponade and hospitalization indicated

 ➢ Urosepsis with hospitalization indicated