Table 1

Baseline and pathologic characteristics of study patients

CharacteristicPlaceboRapamycin (0.5 mg)Rapamycin (2.0 mg)
Number of patients11128
Mean (range) age, years71 (39–87)71 (56–90)73 (62–86)
 Black or African American000
Pathologic stage
Bladder cancer history
 Mean (range) time (months) from TURBT19 (3–49)15 (3–36)18 (3–45)
 Mean (range) time (months) from last pre-enrolment BCG4 (1–9)6 (1–42)7 (1–20)
 Prior non-BCG intravesical therapy243
 Prior BCG failure*573
Disease status
  • *Using FDA classification as described here: US Food and Drug Administration. BCG-unresponsive non-muscle invasive bladder cancer: developing drugs and biologics for treatment guidance for industry. Office of Communications, Division of Drug Information, Silver Spring, MD. 2018:1-0.

  • CIS, carcinoma in situ; TURBT, transurethral resection of bladder tumor.