Table 2.
Summary of exposure to study treatment
| 50 mg (N = 2) | 100 mg (N = 1) | 200 mg (N = 1) | 400 mg (N = 1) | 800 mg (N = 3) | 1,200 mg (N = 4) | 1,800 mg (N = 10) | 2,400 mg (N = 12) | 3,000 mg (N = 7) | Total (N = 41) | |
|---|---|---|---|---|---|---|---|---|---|---|
| Dose intensity (mg/cycle)a | ||||||||||
| N | 2 | 1 | 1 | 1 | 3 | 4 | 10 | 12 | 7 | 41 |
| Mean | 183.3 | 680.0 | 1,200.0 | 2,400.0 | 4,932.6 | 6,850.0 | 9,906.4 | 1,2393.3 | 1,2678.6 | 9,350.7 |
| SD | 47.14 | - | - | - | 1,284.58 | 412.31 | 1,473.89 | 1,856.04 | 5,817.92 | 4,737.17 |
| Median | 183.3 | - | - | - | 4,400.0 | 6,900.0 | 10,277.1 | 12,600.0 | 1,4250.0 | 9,900.0 |
| Min | 150 | - | - | - | 4,000 | 6,400 | 6,300 | 9,600 | 3,000 | 150 |
| Max | 217 | - | - | - | 6,398 | 7,200 | 11,550 | 14,400 | 18,000 | 18,000 |
| Number of cycles | ||||||||||
| N | 2 | 1 | 1 | 1 | 3 | 4 | 10 | 12 | 7 | 41 |
| Mean | 2.0 | 5.0 | 2.0 | 2.0 | 3.0 | 2.3 | 3.8 | 2.3 | 2.4 | 2.8 |
| SD | 1.41 | - | - | - | 2.65 | 0.50 | 1.87 | 1.42 | 1.90 | 1.70 |
| Median | 2.0 | - | - | - | 2.0 | 2.0 | 3.5 | 2.0 | 2.0 | 2.0 |
| Min | 1 | - | - | - | 1 | 2 | 2 | 1 | 1 | 1 |
| Max | 3 | - | - | - | 6 | 3 | 7 | 5 | 6 | 7 |
| Number of cycles | ||||||||||
| ≤2 | 1 (50%) | 0 | 1 (100%) | 1 (100%) | 2 (67%) | 3 (75%) | 4 (40%) | 8 (67%) | 5 (71%) | 25 (61%) |
| 3–5 | 1 (50%) | 1 (100%) | 0 | 0 | 0 | 1 (25%) | 4 (40%) | 4 (33%) | 1 (14%) | 12 (29%) |
| >5 | 0 | 0 | 0 | 0 | 1 (33%) | 0 | 2 (20%) | 0 | 1 (14%) | 4 (10%) |
a
Dose intensity (mg/cycle) is the average dose per cycle and is multiplied by the number of doses planned for each cycle.