Table 3.
Safety in the treated population of the Western European cohort
| Safety, n (%) |
nab-P + Gem (n=39)a |
Gem (n=36) |
|---|---|---|
| Patients with ≥1 AE leading to death | 2 (5) | 2 (6) |
| Grade ≥3 hematologic AEs in >10% of patients in either armb | (n=37) | |
| Neutropenia | 17 (46) | 12 (33) |
| Leukopenia | 13 (35) | 7 (19) |
| Anemia | 8 (22) | 0 |
| Thrombocytopenia | 5 (14) | 1 (3) |
| Grade ≥3 nonhematologic AEs in >10% of patients in either armc | ||
| Asthenia | 8 (21) | 2 (6) |
| Peripheral neuropathyd | 5 (13) | 1 (3) |
| Alopecia | 4 (10) | 0 |
Notes:
a
One patient was randomized to the Gem-only arm but received nab-paclitaxel plus gemcitabine;
b
Assessment of the event was made on the basis of laboratory values;
c
Assessment of the event was made on the basis of investigator assessment of treatment-related AEs;
d
Peripheral neuropathy was reported on the basis of groupings of preferred terms, defined by standardized queries in the Medical Dictionary for Regulatory Activities.
Abbreviations: AE, adverse event; Gem, gemcitabine; nab-P, nab-paclitaxel.