Table 1:
Baseline characteristics of the intention-to-treat population
| Ramucirumab plus docetaxel (n=263) | Placebo plus docetaxel (n=267) | |
|---|---|---|
| Age (years) | 65 (59–72) | 66 (59–72) |
| ≥65 | 139 (53%) | 152 (57%) |
| Sex | ||
| Male | 213 (81%) | 215 (81%) |
| Female | 50 (19%) | 52 (19%) |
| Ethnicity | ||
| White | 203 (77%) | 204 (76%) |
| Asian | 54 (21%) | 61 (23%) |
| Other | 4 (2%) | 2 (<1%) |
| Missing | 2 (<1%) | 0 |
| ECOG performance status | ||
| 0 | 121 (46%) | 125 (47%) |
| 1 | 139 (53%) | 142 (53%) |
| Missing | 3 (1%) | 0 |
| Geographic region | ||
| North America | 24 (9%) | 24 (9%) |
| Europe and rest of the world | 186 (71%) | 186 (70%) |
| East Asia | 53 (20%) | 57 (21%) |
| Histology | ||
| Pure transitional cell | 205 (78%) | 217 (81%) |
| Mixed histology | 55 (21%) | 49 (18%) |
| Missing | 3 (1%) | 1 (<1%) |
| Duration of disease (months)* | 18·0 (10·4–36·4) | 17·0 (11·0–34·6) |
| Bladder as primary site of tumour | 180 (68%) | 177 (66%) |
| Visceral metastases | 182 (69%) | 188 (70%) |
| Lung metastases | 98 (37%) | 121 (45%) |
| Liver metastases | 78 (30%) | 69 (26%) |
| Bone metastases | 56 (21%) | 53 (20%) |
| Adrenal gland | 15 (6%) | 12 (4%) |
| Kidney | 13 (5%) | 10 (4%) |
| Spleen | 4 (2%) | 5 (2%) |
| Other | 35 (13%) | 28 (10%) |
| Lymph-node-only disease | 41 (16%) | 42 (16%) |
| Creatinine clearance (mL/min) | ||
| <60 | 106 (40%) | 118 (44%) |
| ≥60 | 151 (57%) | 146 (55%) |
| Missing | 6 (2%) | 3 (1%) |
| Haemoglobin concentration <10 g/dL | 34 (13%) | 36 (13%) |
| Completion or discontinuation of most recent therapy <3 months | 115 (44%) | 126 (47%) |
| Bellmunt risk factors (n)† | ||
| 0 | 88 (33%) | 93 (35%) |
| 1 | 105 (40%) | 109 (41%) |
| 2 | 64 (24%) | 57 (21%) |
| 3 | 6 (2%) | 8 (3%) |
| Previous adjuvant treatment | ||
| Adjuvant | 46 (17%) | 70 (26%) |
| Neoadjuvant | 41 (16%) | 37 (14%) |
| No previous adjuvant | 173 (66%) | 160 (60%) |
| Missing | 3 (1%) | 0 |
| Previous treatments‡ | ||
| Cisplatin-based | 161 (61%) | 189 (71%) |
| Carboplatin-based | 97 (37%) | 77 (29%) |
| Immune checkpoint inhibitor | 17 (6%) | 28 (10%) |
Data are median (IQR) or n (%), unless otherwise indicated. ECOG=Eastern Cooperative Oncology Group.
*
Data are median (IQR).
†
Bellmunt risk factors included liver metastases, haemoglobin <10 g/dL, and ECOG performance status score >0.
‡
A summary of previous anticancer treatments is included in the appendix (p 12).