Table 1. Baseline Characteristics of All Randomized, Eligible Participants.
| Characteristics | No. (%) of Participantsa | |
|---|---|---|
| Gemcitabine Group (n = 201) | Saline Group (n = 205) | |
| Age, median (IQR), y | 66 (59-74) | 66 (59-75) |
| Male sex | 163 (81) | 181 (88) |
| Race | ||
| White | 186 (93) | 185 (90) |
| Black | 6 (3) | 9 (4) |
| Asian | 4 (2) | 5 (2) |
| American Indian | 0 | 2 (1) |
| Unknown | 5 (2) | 4 (2) |
| ECOG performance status, 0 (vs 1)c | 157 (78) | 165 (80) |
| Smoking history | ||
| Current | 49 (24) | 54 (26) |
| Prior | 98 (49) | 101 (49) |
| Never | 54 (27) | 46 (22) |
| Unknown | 0 | 4 (2) |
| Occurrence, first (vs recurrent) | 128 (64) | 128 (62) |
| No. of tumors at index TURBT, 1 (vs ≥2) | 135 (67) | 140 (68) |
| Pathologic findings among patients who received TURBT and drug instillation | (n = 168) | (n = 177) |
| No cancer or inadequate pathology specimenb | 17 (10) | 14 (8) |
| Stage T2 tumor | 5 (3) | 8 (5) |
| High-grade non–muscle-invasive disease | 44 (26) | 42 (24) |
| Low-grade non–muscle-invasive disease | 102 (61) | 113 (64) |
| Prior intravesical therapy | ||
| All types | 39 (19) | 39 (19) |
| Bacille Calmette-Guérin | 18 | 25 |
| Adriamycin | 1 | 0 |
| Mitomycin C | 1 | 2 |
| Not specified | 19 | 12 |
Abbreviations: IQR, interquartile range; TURBT: transurethral resection of bladder tumor.
a
Data are expressed as No. (%) of participants unless otherwise indicated.
b
Inadequate pathology specimen indicates that based on scantiness of the specimen, the pathologist was unable to assess to unequivocally diagnose a benign condition or bladder cancer.
c
Eastern Cooperative Oncology Group (ECOG) performance status scores20: 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; eg, light housework, office work.