Table 1.
Baseline patient and disease characteristics (ITT population)
| Characteristics | ITT population (N = 403) |
|---|---|
| Age (years) | |
| Mean (SD) | 69.9 (10.7) |
| Sex, n (%) | |
| Female | 114 (28.3) |
| Male | 289 (71.7) |
| Current diagnosis is based on n (%) | |
| Positive urine cytology | 34 (8.4) |
| Cystoscopy results | 356 (88.3) |
| Other | 65 (16.1) |
| Suspicion of NMIBC, n (%) | |
| Primary tumour | 275 (68.2) |
| Recurrence | 126 (31.3) |
| Missing | 2 (0.5) |
| Suspicion of CIS, n (%) | |
| Yes | 51 (12.7) |
| No | 350 (86.8) |
| Missing | 2 (0.5) |
| Suspicion of high-grade tumour, n (%) | |
| Yes | 83 (20.6) |
| No | 318 (78.9) |
| Missing | 2 (0.5) |
| Previous BCG instillation, n (%) | 20 (5.0) |
| Mean time between first diagnosis and end of the last BCG instillation (months) | 27.1 |
| EORTC recurrence riska,b | |
| High risk | 5 (2.3) |
| Intermediate risk | 181 (83.4) |
| Low risk | 31 (14.3) |
| Missing | 65 |
| EORTC progression riska,b | |
| High risk | 65 (30.0) |
| Intermediate risk | 102 (47.0) |
| Low risk | 50 (23.0) |
| Missing | 65 |
BCG Bacillus Calmette–Guérin, CIS carcinoma in situ, EORTC European organisation for research and Treatment of cancer, NMIBC non-muscle invasive bladder cancer, SD standard deviation
aPercentages are calculated based on the number of histologically evaluated patients with cancerous lesions (n = 282) minus missing patients (n = 65), i.e. N = 217
bEORTC is only applicable to patients with cancerous lesions, with respective stage Ta, T1, and CIS