Table 1.
Summary of baseline demographics and other characteristics of the patients in the IPATential150 study analysis data set
| Variable | Placebo | 400 mg | Total |
|---|---|---|---|
| N | 554 | 547 | 1101 |
| Age (years) | 70 (69.6) [44; 90] | 69 (69.3) [47; 93] | 70 (69.5) [44; 93] |
| Body weight (kg) | 82 (84.1) [51; 166] {4} | 81 (81.8) [46; 143] {1} | 82 (83) [46; 166] {5} |
| ECOG status | |||
| 0 | 401 (72.4%) | 421 (77.0%) | 822 (74.7%) |
| ≥ 1 | 150 (27.1%) | 125 (22.9%) | 275 (25.0%) |
| Race | |||
| White | 386 (69.7%) | 376 (68.7%) | 762 (69.2%) |
| Black or African American | 9 (1.62%) | 10 (1.83%) | 19 (1.73%) |
| Asian | 109 (19.7%) | 110 (20.1%) | 219 (19.9%) |
| American Indian or Alaska Native | 16 (2.89%) | 15 (2.74%) | 31 (2.82%) |
| Native Hawaiian or Other Pacific Islander | 1 (0.181%) | 1 (0.183%) | 2 (0.182%) |
| Unknown | 33 (5.96%) | 35 (6.4%) | 68 (6.18%) |
| Region | |||
| United States | 74 (13.4%) | 70 (12.8%) | 144 (13.1%) |
| Asia–Pacific | 141 (25.5%) | 136 (24.9%) | 277 (25.2%) |
| EU | 280 (50.5%) | 281 (51.4%) | 561 (51%) |
| Rest of World | 59 (10.6%) | 60 (11%) | 119 (10.8%) |
| Visceral metastasis | |||
| No visceral metastasis | 476 (85.9%) | 473 (86.5%) | 949 (86.2%) |
| Visceral metastasis | 78 (14.1%) | 74 (13.5%) | 152 (13.8%) |
| Tumor PTEN status | |||
| Loss | 261 (47.1%) | 260 (47.5%) | 521 (47.3%) |
| Non-loss | 293 (52.9%) | 287 (52.5%) | 580 (52.7%) |
| Progression factor | |||
| Yes | 277 (50%) | 273 (49.9%) | 550 (50%) |
| No | 277 (50%) | 274 (50.1%) | 551 (50%) |
| Prior taxane therapy | |||
| Yes | 99 (17.9%) | 98 (17.9%) | 197 (17.9%) |
| No | 455 (82.1%) | 449 (82.1%) | 904 (82.1%) |
| Baseline glucose (mmol/L) | 5.88 (6.01) [3.1; 10.6] {84} | 5.8 (5.95) [0.294; 14] {82} |
5.83 (5.98) [0.294; 14] {166} |
| Baseline HbA1c (%) | 38.8 (46.1) [5.2; 589] {10} | 39 (45.1) [5.4; 604] {8} | 38.8 (45.6) [5.2; 604] {18} |
Continuous variables are expressed as median (geometric mean) [range] {missing}. Categorical variables are expressed as count (percentage)