2. Participants in the included study.
Study name | Interventions and comparators | Screened/eligible (n) | Randomized (n) | Analyzed (n): efficacy | Analyzed (n): safety | Finishing trial (n (%)) |
Addeo 2010 | Intervention: gemcitabine 2000 mg/50 mL saline | 120/109 | 54 | 54 | 54 | 54 (100) |
Comparator: mitomycin 40 mg/50 mL saline | 55 | 55 | 55 | 55 (100) | ||
Bendary 2011 | Intervention: gemcitabine 2000 mg/50 mL saline | NA/80 | 40 | NA | NA | NA |
Comparator: BCG 6 × 108 CFU/50 mL saline | 40 | NA | NA | NA | ||
Böhle 2009 | Intervention: gemcitabine 2000 mg/100 mL saline | NA/355 | 179 | Primary outcome; 166/secondary outcome; 124 | 166 | 41 (22.9) |
Comparator: 100 mL saline | 176 | Primary outcome; 162/secondary outcome; 124 | 162 | 47 (26.7) | ||
Di Lorenzo 2010 | Intervention: gemcitabine 2000 mg/50 mL saline | 92/80 | 40 | 40 | 40 | 40 (100) |
Comparator: BCG (Connaught strain, 81 mg/50 mL saline) | 40 | 40 | 40 | 40 (100) | ||
Gontero 2013 | Intervention: gemcitabine 2000 mg/50 mL saline | 120/118 | 59 | 41 | 41 | 41 (100) |
Comparator: 1/3 dose BCG (Connaught strain, 27 mg/50 mL saline) | 59 | 47 | 47 | 47 (100) | ||
Messing 2018 | Intervention: gemcitabine 2000 mg/100 mL saline | NA/416 | 207 | 201 | 165 | 102 (49.3) |
Comparator: 100 mL saline | 209 | 205 | 175 | 113 (54.1) | ||
Porena 2010 | Intervention: gemcitabine 2000 mg/50 mL saline | 74/64 | 32 | 32 | 32 | 32 (100) |
Comparator: BCG (Tice strain) 5 × 108 CFU/50 mL saline | 32 | 32 | 32 | 32 (100) | ||
Intervention: gemcitabine | 611 | — | — | 310a | ||
Comparator: mitomycin | 55 | — | — | 55 (100) | ||
Comparator: BCG | 171 | — | — | 119a | ||
Comparator: saline | 385 | — | — | 160 (62.3) | ||
Grand total | 1222 | — | — | 644 (52.7)b |
BCG: Bacillus Calmette‐Guérin; CFU: colony‐forming units; n: number of participants; NA: not available. aBendary 2011 did not report the number of participants who finished trial. bCalculated without Bendary 2011.