Table 3. Common Adverse Events of Grade 3 or Higher and Growth-Factor Use*.
| Event | nab-Paclitaxel plus Gemcitabine (N = 421) |
Gemcitabine Alone (N = 402) |
|---|---|---|
| Adverse event leading to death — no. (%) | 18 (4) | 18 (4) |
| Grade ≥3 hematologic adverse event — no./total no. (%)† | ||
| Neutropenia | 153/405 (38) | 103/388 (27) |
| Leukopenia | 124/405 (31) | 63/388 (16) |
| Thrombocytopenia | 52/405 (13) | 36/388 (9) |
| Anemia | 53/405 (13) | 48/388 (12) |
| Receipt of growth factors — no./total no. (%) | 110/431 (26) | 63/431 (15) |
| Febrile neutropenia — no. (%)‡ | 14 (3) | 6 (1) |
| Grade ≥3 nonhematologic adverse event occurring in >5% of patients — no. (%)‡ |
||
| Fatigue | 70 (17) | 27 (7) |
| Peripheral neuropathy§ | 70 (17) | 3 (1) |
| Diarrhea | 24 (6) | 3 (1) |
| Grade ≥3 peripheral neuropathy | ||
| Median time to onset — days | 140 | 113 |
| Median time to improvement by one grade — days | 21 | 29 |
| Median time to improvement to grade ≤1 — days | 29 | NR |
| Use of nab-paclitaxel resumed — no./total no. (%) | 31/70 (44) | NA |
*
NA denotes not applicable, and NR not reached.
†
Assessment of the event was made on the basis of laboratory values.
‡
Assessment of the event was made on the basis of investigator assessment of treatment-related adverse events.
§
Peripheral neuropathy was reported on the basis of groupings of preferred terms defined by standardized queries in the Medical Dictionary for Regulatory Activities.