Table 2.
TEAEs of any grade in > 15% of patients and/or of grade ≥ 3 in > 5% of patients in either arm in the safety population.
| Efti + Paclitaxel | Placebo + Paclitaxel | |||
|---|---|---|---|---|
| (n = 114) | (n = 112) | |||
| Event, n (%) | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 |
| Fatigue | 53 (46.5) | 2 (1.8) | 55 (49.1) | 2 (1.8) |
| Alopecia | 46 (40.4) | 0 | 56 (50.0) | 0 |
| Nausea | 44 (38.6) | 3 (2.6) | 40 (35.7) | 0 |
| Diarrhea | 33 (28.9) | 1 (0.9) | 41 (36.6) | 1 (0.9) |
| GGT increased | 25 (21.9) | 23 (20.2) | 34 (30.4) | 33 (29.5) |
| Peripheral neuropathy | 23 (20.2) | 0 | 28 (25.0) | 1 (0.9) |
| Injection site reaction | 39 (34.2) | 0 | 4 (3.6) | 0 |
| Peripheral sensory neuropathy | 21 (18.4) | 0 | 22 (19.6) | 2 (1.8) |
| Neutropenia | 22 (19.3) | 18 (15.8) | 21 (18.8) | 16 (14.3) |
| Cough | 20 (17.5) | 0 | 22 (19.6) | 0 |
| Constipation | 20 (17.5) | 0 | 20 (17.9) | 0 |
| Headache | 21 (18.4) | 0 | 17 (15.2) | 1 (0.9) |
| Injection site erythema | 35 (30.7) | 1 (0.9) | 2 (1.8) | 0 |
| Asthenia | 16 (14.0) | 1 (0.9) | 20 (17.9) | 0 |
| Dyspnea | 16 (14.0) | 2 (1.8) | 20 (17.9) | 4 (3.6) |
| AST increased | 16 (14.0) | 10 (8.8) | 18 (16.1) | 13 (11.6) |
| Anemia | 18 (15.8) | 7 (6.1) | 16 (14.3) | 1 (0.9) |
| Peripheral edema | 8 (7.0) | 0 | 19 (17.0) | 1 (0.9) |
| Blood ALP increased | 9 (7.9) | 5 (4.4) | 14 (12.5) | 10 (8.9) |
| ALT increased | 10 (8.8) | 5 (4.4) | 12 (10.7) | 7 (6.3) |
| WBC count decreased | 5 (4.4) | 4 (3.5) | 11 (9.8) | 7 (6.3) |
| Lymphocyte count decreased | 3 (2.6) | 3 (2.6) | 7 (6.3) | 7 (6.3) |
| Neutrophil count decreased | 2 (1.8) | 2 (1.8) | 6 (5.4) | 6 (5.4) |
| Hypophosphatemia | 2 (1.8) | 1 (0.9) | 9 (8.0) | 9 (8.0) |
| Hypertension | 14 (12.3) | 7 (6.1) | 11 (9.8) | 3 (2.7) |
Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl aminotransferase; WBC, white blood cell.