Table 3.
Most common treatment-related grade ≥2 adverse events reported in ≥5% patients
| Preferred terms |
nab-Paclitaxel (N = 257) |
Dacarbazine (N =
258) |
||||
|---|---|---|---|---|---|---|
| Treatment-related death | 2 (<1) |
1 (<1) |
||||
| Grade 2 | Grade 3 | Grade 4 | Grade 2 | Grade 3 | Grade 4 | |
| Hematologic AEs, n (%)a | ||||||
| Neutropenia | 67 (26) | 42 (17) | 8 (3) | 34 (14) | 14 (6) | 11 (4) |
| Leukopenia | 93 (37) | 30 (12) | 1 (<1) | 48 (20) | 14 (6) | 3 (1) |
| Lymphocytopenia | 63 (25) | 18 (7) | 1 (<1) | 71 (29) | 23 (9) | 4 (2) |
| Thrombocytopenia | 0 ( | 0 ( | 0 ( | 14 (6) | 9 (4) | 6 (2) |
| Anemia | 52 (21) | 4 (2) | 0 ( | 31 (13) | 12 (5) | 0 ( |
| Nonhematologic AEs, n (%)a | ||||||
| Alopecia | 101 (39) | 12 (5) | 0 ( | 0 ( | 0 ( | 0 ( |
| Peripheral neuropathyb | 42 (16) | 62 (24) | 2 (<1) | 1 (<1) | 0 ( | 0 ( |
| Fatigue | 47 (18) | 21 (8) | 0 ( | 33 (13) | 4 (2) | 0 ( |
| Diarrhea | 24 (9) | 3 (1) | 0 ( | 11 (4) | 1 (<1) | 0 ( |
| Nausea | 22 (9) | 1 (<1) | 0 ( | 20 (8) | 3 (1) | 0 ( |
| Rash | 23 (9) | 1 (<1) | 0 ( | 1 (<1) | 0 ( | 0 ( |
| Nail disorder | 21 (8) | 3 (1) | 0 ( | 0 ( | 0 ( | 0 ( |
aBased on central laboratory values. Except for lymphocytopenia, all events across all grades (Cochran–Mantel–Haenszel test) and for grade 3 and 4 (Fisher's exact test) P < 0 (.05.
bPeripheral neuropathy was classified based on Standardized MedDRA Queries (SMQ) (broad scope).
AE, adverse event; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.