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)
Sex
 Male8118
 Female310
Race
 Asian100
 Black or African American000
 White10128
 Other000
Ethnicity
 Non-Spanish887
 Spanish/Hispanic/Latino341
Pathologic stage
 CIS230
 Ta754
 T1031
 CIS+Ta012
 CIS+T1100
 Ta+T1101
Grade
 Low120
 High894
 Low+high214
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
 Primary633
 Recurrent595
  • *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.