Summary of pralatrexate exposure
| . | Cohort 1 CHOP + pralatrexate 10 mg/m2 (n = 4) . | Cohort 2 CHOP + pralatrexate 15 mg/m2 (n = 3) . | Cohort 3 CHOP + pralatrexate 20 mg/m2 (n = 3) . | Cohort 4 CHOP + pralatrexate 25 mg/m2 (n = 3) . | Cohort 5 CHOP + pralatrexate 30 mg/m2 (n = 6) . | Expansion CHOP + pralatrexate 30 mg/m2 (n = 33) . | Total (N = 52) . | |
|---|---|---|---|---|---|---|---|---|
| Number of cycles administered | n | 4 | 3 | 3 | 3 | 6 | 33 | 52 |
| Mean | 6.00 | 5.33 | 6.00 | 6.00 | 5.17 | 4.88 | 5.15 | |
| SD | 0.000 | 1.155 | 0.000 | 0.000 | 1.602 | 1.816 | 1.601 | |
| Median | 6.00 | 6.00 | 6.00 | 6.00 | 6.00 | 6.00 | 6.00 | |
| Min, Max | 6.0, 6.0 | 4.0, 6.0 | 6.0, 6.0 | 6.0, 6.0 | 2.0, 6.0 | 1.0, 6.0 | 1.0, 6.0 | |
| Total cumulative dose received (mg/m2) | n | 4 | 3 | 3 | 3 | 6 | 33 | 52 |
| Mean | 247.95 | 279.20 | 474.67 | 598.00 | 541.33 | 490.84 | 471.02 | |
| SD | 38.630 | 22.098 | 16.653 | 93.016 | 246.676 | 223.193 | 213.381 | |
| Median | 262.50 | 281.60 | 480.00 | 600.00 | 566.50 | 532.00 | 484.10 | |
| Min, Max | 190.8, 276.0 | 256.0, 300.0 | 456.0, 488.0 | 504.0, 690.0 | 189.0, 804.0 | 50.0, 864.0 | 50.0, 864.0 | |
| Relative dose intensity (%) | n | 4 | 3 | 3 | 3 | 6 | 33 | 52 |
| Mean | 102.07 | 100.18 | 99.36 | 98.14 | 97.04 | 97.64 | 98.19 | |
| SD | 2.585 | 2.210 | 2.372 | 1.566 | 14.163 | 11.831 | 10.500 | |
| Median | 101.76 | 99.80 | 99.48 | 97.49 | 101.78 | 100.40 | 100.39 | |
| Min, Max | 99.6, 105.2 | 98.2, 102.6 | 96.9, 101.7 | 97.0, 99.9 | 68.5, 106.9 | 69.2, 137.5 | 68.5, 137.5 | |
| . | Cohort 1 CHOP + pralatrexate 10 mg/m2 (n = 4) . | Cohort 2 CHOP + pralatrexate 15 mg/m2 (n = 3) . | Cohort 3 CHOP + pralatrexate 20 mg/m2 (n = 3) . | Cohort 4 CHOP + pralatrexate 25 mg/m2 (n = 3) . | Cohort 5 CHOP + pralatrexate 30 mg/m2 (n = 6) . | Expansion CHOP + pralatrexate 30 mg/m2 (n = 33) . | Total (N = 52) . | |
|---|---|---|---|---|---|---|---|---|
| Number of cycles administered | n | 4 | 3 | 3 | 3 | 6 | 33 | 52 |
| Mean | 6.00 | 5.33 | 6.00 | 6.00 | 5.17 | 4.88 | 5.15 | |
| SD | 0.000 | 1.155 | 0.000 | 0.000 | 1.602 | 1.816 | 1.601 | |
| Median | 6.00 | 6.00 | 6.00 | 6.00 | 6.00 | 6.00 | 6.00 | |
| Min, Max | 6.0, 6.0 | 4.0, 6.0 | 6.0, 6.0 | 6.0, 6.0 | 2.0, 6.0 | 1.0, 6.0 | 1.0, 6.0 | |
| Total cumulative dose received (mg/m2) | n | 4 | 3 | 3 | 3 | 6 | 33 | 52 |
| Mean | 247.95 | 279.20 | 474.67 | 598.00 | 541.33 | 490.84 | 471.02 | |
| SD | 38.630 | 22.098 | 16.653 | 93.016 | 246.676 | 223.193 | 213.381 | |
| Median | 262.50 | 281.60 | 480.00 | 600.00 | 566.50 | 532.00 | 484.10 | |
| Min, Max | 190.8, 276.0 | 256.0, 300.0 | 456.0, 488.0 | 504.0, 690.0 | 189.0, 804.0 | 50.0, 864.0 | 50.0, 864.0 | |
| Relative dose intensity (%) | n | 4 | 3 | 3 | 3 | 6 | 33 | 52 |
| Mean | 102.07 | 100.18 | 99.36 | 98.14 | 97.04 | 97.64 | 98.19 | |
| SD | 2.585 | 2.210 | 2.372 | 1.566 | 14.163 | 11.831 | 10.500 | |
| Median | 101.76 | 99.80 | 99.48 | 97.49 | 101.78 | 100.40 | 100.39 | |
| Min, Max | 99.6, 105.2 | 98.2, 102.6 | 96.9, 101.7 | 97.0, 99.9 | 68.5, 106.9 | 69.2, 137.5 | 68.5, 137.5 | |