Table 1.
Demographic and baseline characteristics of the cardiac safety population
| Parameter | Safety population (n = 44) | Cardiac safety population (n = 30) |
|---|---|---|
| Age, year | ||
| Mean | 59.0 | 58.9 |
| SD | 8.86 | 8.10 |
| Median | 59.0 | 58.0 |
| Minimum, maximum | 39, 78 | 41, 77 |
| Gender, n (%) | ||
| Male | 22 (50.0) | 15 (50.0) |
| Female | 22 (50.0) | 15 (50.0) |
| Race, n (%) | ||
| White | 38 (86.4) | 26 (86.7) |
| Black, of African heritage | 3 (6.8) | 2 (6.7) |
| Asian | 2 (4.5) | 2 (6.7) |
| American Indian or Alaskan Native | 1 (2.3) | 0 |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 1 (2.3) | 1 (3.3) |
| Not Hispanic or Latino | 43 (97.7) | 29 (96.7) |
| Body surface area, m2 | ||
| Mean | 1.92 | 1.91 |
| SD | 0.283 | 0.253 |
| Median | 1.91 | 1.88 |
| Minimum, maximum | 1.44, 2.66 | 1.48, 2.34 |
| ECOG performance status, n (%) | ||
| 0 | 29 (65.9) | 21 (70.0) |
| 1 | 15 (34.1) | 9 (30.0) |
| Cancer type, n (%) | ||
| Cervical | 2 (4.5) | 1 (3.3) |
| Colon | 32 (72.7) | 23 (76.7) |
| Rectal | 1 (2.3) | 1 (3.3) |
| Esophageal | 2 (4.5) | 0 |
| Pancreatic | 3 (6.8) | 3 (10.0) |
| Renal | 2 (4.5) | 1 (3.3) |
| Uterine | 1 (2.3) | 0 |
| Other | 1 (2.3) | 1 (3.3) |
| Prior surgery/biopsy related to cancer,a n (%) | ||
| Yes (excludes patients with biopsy only) | 35 (79.5) | 23 (76.7) |
| Primary | 27 (61.4) | 16 (53.3) |
| Other | 19 (43.2) | 13 (43.3) |
| Biopsy | 34 (77.3) | 24 (80.0) |
| No | 0 | 0 |
| Prior radiotherapy | ||
| Yes | 18 (40.9) | 12 (40.0) |
| No | 26 (59.1) | 18 (60.0) |
| Prior systemic cancer therapy,b n (%) | ||
| Yes | 44 (100) | 30 (100) |
| Intent of prior systemic cancer therapy,a n (%) | ||
| Neoadjuvant | 8 (18.2) | 5 (16.7) |
| Adjuvant | 15 (34.1) | 8 (26.7) |
| Metastatic | 40 (90.9) | 28 (93.3) |
| Number of prior regimens,b n (%) | ||
| 1 | 1 (2.3) | 0 |
| 2 | 10 (22.7) | 7 (23.3) |
| 3 | 7 (15.9) | 5 (16.7) |
| ≥4 | 26 (59.1) | 18 (60.0) |
SD standard deviation; ECOG Eastern Cooperative Oncology Group
aPatients with multiple levels are counted in each applicable category
bIncluded all prior systemic therapies (neoadjuvant, adjuvant, metastatic)