Table 5.
Adverse events in patients in Canada and the treated population
| Grade ≥3 AEs | Patients in Canada | All treated patients [9] | ||
|---|---|---|---|---|
| nab-P + Gem (n = 32) | Gem (n = 30) | nab-P + Gem (n = 421) | Gem (n = 402) | |
| Patients with at least 1 grade ≥3 AE, n (%) | 30 (94) | 22 (73) | NR | NR |
| Hematologic AEs, n (%) | ||||
| Neutropenia | 7 (22) | 3 (10) | 153 (38)a | 103 (27)b |
| Anemia | 3 (9) | 2 (7) | 53 (13)a | 48 (12)b |
| Thrombocytopenia | 2 (6) | 1 (3) | 52 (13)a | 36 (9)b |
| Leukopenia | 1 (3) | 0 | 124 (31)a | 63 (16)b |
| Nonhematologic AEs, n (%) | ||||
| Fatigue | 11 (34) | 10 (33) | 70 (17) | 27 (7) |
| Peripheral neuropathyc | 8 (25) | 0 | 70 (17) | 3 (1) |
| Vomiting | 2 (6) | 4 (13) | NR | NR |
AE adverse event, Gem gemcitabine, nab-P nab-paclitaxel, NR not reported
aTotal evaluable patients in the population = 405
bTotal evaluable patients in the population = 388
cGrouped AE term