Table 2 Extent of exposure (safety population)
Endpoint | Etirinotecan pegol (n = 425) | TPC (n = 406) |
|---|---|---|
Overall exposure duration, days | ||
Median | 48.0 | 56.5 |
Mean (SD) | 103.0 ± 117.8 | 99.5 ± 98.3 |
Cycles completed, n | ||
Median | 3.0 | 3.0 |
Mean (SD) | 5.5 ± 5.2 | 5.0 ± 4.2 |
Relative dose intensity, %a | ||
Median | 98.3 | 92.8 |
Mean (SD) | 92.6 ± 10.7 | 89.1 ± 16.2 |
Patient who had any dose reduction, n | 117 (27.5 %) | 115 (28.3 %) |
Due to AE | 117 (27.5 %) | 108 (26.6 %) |
Other reason(s) | 0 (0.0 %) | 9 (2.2 %) |
Patients who had any dose delay, n | 178 (41.9 %) | 190 (46.8 %) |
Due to AE | 151 (35.5 %) | 150 (36.9 %) |
Other reason(s) | 72 (16.9 %) | 88 (21.7) |
Patients who had any dose interruption, n | 18 (4.2 %) | 8. (2.0 %) |
Due to AE | 15 (3.5 %) | 7 (1.7 %) |
Other reason(s) | 4 (0.9 %) | 1 (0.2 %) |
Number of cycles with dose reduction or delay due to AEb | 276 (11.8 %) | 397 (19.7 %) |