Table 3.
Adverse events occur in ⩾5% of patients in any treatment arm (N=174).
| AEs | NPLS (175 mg/m2) (N = 85) Arm A, n (%) |
NPLS (80 mg/m2) (N = 45) Arm B, n (%) |
Conventional paclitaxel (175 mg/m2) (N = 44) Arm C, n (%) |
|||
|---|---|---|---|---|---|---|
| Grade 1–2 | Grade ⩾3 | Grade 1–2 | Grade ⩾3 | Grade 1–2 | Grade ⩾3 | |
| Alopecia | 18 (21) | 0 | 8 (18) | 0 | 9 (20) | 0 |
| Anemia | 6 (7) | 2 (2) | 9 (20) | 4 (9) | 4 (9) | 0 |
| Asthenia | 11 (13) | 0 | 2 (4) | 0 | 4 (9) | 0 |
| Back pain | 9 (11) | 1 (1) | 5 (11) | 2 (4) | 0 | 0 |
| Chest discomfort | 1 (1) | 0 | 0 | 0 | 3 (7) | 0 |
| Chills | 18 (21) | 1 (1) | 8 (18) | 3 (7) | 1 (2) | 0 |
| Cough | 4 (5) | 0 | 6 (13) | 0 | 3 (7) | 0 |
| Decreased appetite | 5 (6) | 0 | 0 | 0 | 5 (11) | 0 |
| Diarrhea | 5 (6) | 0 | 4 (9) | 0 | 5 (11) | 0 |
| Dyspnea | 4 (5) | 1 (1) | 7 (16) | 0 | 0 | 1 (2) |
| Edema peripheral | 0 | 0 | 4 (9) | 0 | 0 | 0 |
| Headache | 4 (5) | 1 (1) | 1 (2) | 3 (7) | 2 (4) | 0 |
| Hypertension | 2 (2) | 0 | 4 (9) | 2 (4) | 1 (2) | 0 |
| Nausea | 6 (7) | 0 | 3 (7) | 0 | 3 (7) | 0 |
| Neutropenia | 11 (13) | 7 (8) | 8 (18) | 3 (7) | 2 (5) | 2 (4) |
| Pain | 11 (13) | 0 | 1 (2) | 1 (2) | 4 (9) | 0 |
| Peripheral sensory neuropathy | 10 (12) | 1 (1) | 1 (2) | 2 (4) | 9 (20) | 1 (2) |
| Pruritus | 3 (3) | 0 | 1 (2) | 0 | 3 (7) | 0 |
| Pyrexia | 14 (16) | 1 (1) | 4 (9) | 1 (2) | 5 (11) | 0 |
| Tachycardia | 3 (3) | 0 | 3 (7) | 0 | 0 | 0 |
| Vomiting | 6 (7) | 0 | 5 (11) | 0 | 3 (7) | 1 (2) |