Table 2.
Statistical summary of patient demographics and characteristics at the time of study entry
| Patient demographics | N (%) | Study designs | N (%) |
|---|---|---|---|
| Gender | Treatment combination | ||
| Female | 87 (51) | ||
| Male | 84 (49) | Paclitaxel/carboplatin | 45 (26) |
| Race | Doxorubicin | 73 (43) | |
| Caucasian | 147 (86) | Monotherapy | 53 (31) |
| African descent | 15 (8.8) | Treatment regimen | |
| Asian (east/southeast) | 2 (1.2) | ||
| Asian (western) | 1 (0.6) | Days 1 and 8 of a 21-day cycle | 145 (85) |
| Native Hawaiian Other Pacific Islander |
1 (0.6) | Day 1 of a 14-day cycle | 26 (15) |
| Other | 5 (2.9) |
| Patient characteristics | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age (years) | Height (cm) | Weight (kg) | BSA (m2) | BMI (kg/m2) | LBM (kg) | TUMR (mm) | CGCL (mL/min) | ALB (g/L) | ALP (U/L) | ALT (U/L) | AST (U/L) | TBI (µmol/L) | |
| All four studies | |||||||||||||
| N | 171 | 170 | 171 | 170 | 170 | 170 | 164 | 143 | 143 | 143 | 144 | 144 | 143 |
| Mean | 56.8 | 170 | 80.6 | 1.90 | 27.6 | 52.5 | 107 | 109 | 37.7 | 99.4 | 26.2 | 22.9 | 7.95 |
| SD | 11.7 | 9.48 | 21.8 | 0.259 | 6.69 | 9.78 | 85.4 | 45.5 | 4.68 | 56.0 | 16.0 | 12.4 | 3.8 |
| Median | 57.0 | 168 | 79.7 | 1.88 | 26.5 | 52.5 | 86.5 | 99.7 | 38.0 | 86.0 | 21.0 | 20.0 | 6.84 |
| Min | 22.0 | 151 | 37.3 | 1.33 | 16.1 | 33.6 | 12.0 | 40.2 | 22.0 | 4.80 | 4.00 | 5.00 | 1.71 |
| Max | 82.0 | 197 | 151 | 2.59 | 53.6 | 79.8 | 571 | 250 | 49.0 | 463 | 88.0 | 96.0 | 25.6 |
| Geo mean | 55.4 | 169 | 77.8 | 1.88 | 26.9 | 51.7 | 80.8 | 100 | 37.4 | 88.8 | 22.1 | 20.4 | 7.13 |
| Geo CV% | 23.7 | 5.56 | 26.7 | 13.7 | 22.7 | 18.8 | 91.8 | 41.2 | 13.4 | 51.2 | 63.6 | 50.3 | 50.6 |
ALB albumin, ALP alkaline phosphatase, ALT alanine transaminase, AST aspartate transaminase, BMI body mass index, BSA body surface area, CGCL Cockcroft–Gault creatinine clearance, CV coefficient of variation, LBM lean body mass, Min minimum, Max maximum, N number of patients, SD standard deviation, TBI total bilirubin, TUMR tumor size