Table 2. Patient characteristics by trial.
| Variable | BB12839 N=414 (63%) | BB19340 N=239 (37%) | Total N=653 (100%) |
|---|---|---|---|
|
Demographics
| |||
| Age at entry (years) a | |||
| Median | 63 | 62 | 63 |
| Range | 29–89 | 32–85 | 29–89 |
| Ethnic race | |||
| White | 364 (88%) | 226 (95%) | 590 (90%) |
| Black | 27 (6%) | 8 (3%) | 35 (6%) |
| Oriental | 7 (2%) | 0 | 7 (1%) |
| Other | 15 (4%) | 5 (2%) | 20 (3%) |
| Missing | 1 | 0 | 1 |
| Sex | |||
| Male | 228 (55%) | 140 (59%) | 368 (56%) |
| Female | 186 (45%) | 99 (41%) | 285 (44%) |
| Treatment | |||
| Gemcitabine | 103 (25%) | 119 (50%) | 222 (34%) |
| Marimistat | 311 (75%) | 120 (50%) | 431 (66%) |
|
Tumour information
| |||
| Cancer stage | |||
| I | 19 (4%) | 13 (5%) | 32 (5%) |
| II | 45 (11%) | 27 (11%) | 72 (11%) |
| III | 76 (19%) | 28 (12%) | 104 (16%) |
| IV | 268 (66%) | 171 (72%) | 439 (68%) |
| Missing | 6 | 0 | 6 |
| Distant metastases | |||
| M0 | 129 (31%) | 65 (27%) | 194 (30%) |
| M1 | 265 (64%) | 171 (72%) | 436 (67%) |
| Missing | 20 (5%) | 3 (1%) | 23 (3%) |
| Regional lymph nodes | |||
| N0 | 153 (37%) | 90 (38%) | 243 (37%) |
| N1 | 164 (40%) | 87 (36%) | 251 (39%) |
| Missing | 97 (23%) | 62 (26%) | 159 (24%) |
| Primary tumour T stage | |||
| T0 | 5 (1%) | 3 (1.5%) | 8 (1.5%) |
| T1 | 114 (30%) | 44 (20%) | 158 (26%) |
| T2 | 90 (24%) | 54 (25%) | 144 (24%) |
| T3 | 167 (44%) | 113 (53%) | 280 (47%) |
| T4 | 6 (1%) | 1 (0.5%) | 7 (1.5%) |
| Missing | 32 | 24 | 56 |
|
Serum chemistry and haematology
| |||
| Laboratory variables | Median (range), missing | Median (range), missing | Median (range), missing |
| AST (SGOT)a | 24 (6–365), 17 | 26 (9–538), 12 | 25 (6–538), 29 |
| Total bilirubina | 13.7 (3.4–277.0), 16 | 13.7 (3.0–135.1), 8 | 13.7 (3.0–277.0), 24 |
| Alkaline phosphatasea | 136 (36–1660), 16 | 157 (35–2064), 8 | 140 (35–2064), 24 |
| Albumina | 38 (22–47), 17 | 38 (24–47), 8 | 38 (22–47), 25 |
| LDHa | 163 (77–1074), 21 | 169 (29–1495), 11 | 164 (29–1495), 32 |
| BUNa | 9.2 (2.9–34.3), 17 | 9.3 (4.3–27.9), 16 | 9.3 (2.9–34.3), 33 |
| CA19/9a | 686 (5–1 000 000), 17 | 800 (8–1 000 000), 30 | 710 (5–1 000 000), 47 |
| Haemoglobina | 12.5 (5.5–16.1), 28 | 12.4 (8.3–19.1), 13 | 12.4 (5.5–19.1), 41 |
| WBCa | 7.6 (2.3–31.6), 28 | 8.3 (2.4–23.7), 13 | 7.9 (2.3–31.6), 41 |
|
Outcome
| |||
| Event indicator | |||
| Alive | 22 (5%) | 19 (8%) | 41 (6%) |
| Dead | 392 (95%) | 220 (92%) | 612 (94%) |
| Follow-up of alive (months) a | |||
| Median | 20.1 | 19.4 | 20.7 |
| Range | 0.9–24.6 | 1.9–23.3 | 0.9–24.6 |
a
Continuous measurements.