Table 2.
Adverse events regardless of attribution to MOXR0916 occurring in ≥10% patients overall.
| 0.2 to 160 mg | 300 mg | 600 mg | 1,200 mg | All patients | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| n = 53 | n = 109 | n = 6 | n = 4 | (N = 172) | ||||||
| Grade | Grade | Grade | Grade | Grade | ||||||
| MedDRA preferred term, n (%) | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 | All | ≥3 |
| Patients with ≥1 AE | 51 (96) | 38 (72) | 103 (95) | 55 (50) | 5 (83) | 2 (33) | 4 (100) | 2 (50) | 163 (95) | 97 (56) |
| Fatigue | 22 (42) | 0 | 30 (28) | 3 (3) | 3 (50) | 1 (17) | 1 (25) | 0 | 56 (33) | 4 (2) |
| Decreased appetite | 18 (34) | 0 | 25 (23) | 1 (1) | 0 | 0 | 0 | 0 | 43 (25) | 1 (1) |
| Malignant neoplasm progression | 17 (32) | 17 (32) | 24 (22) | 24 (22) | 1 (17) | 1 (17) | 0 | 0 | 42 (24) | 42 (24) |
| Nausea | 13 (25) | 0 | 27 25) | 2 (2) | 1 (17) | 0 | 1 (25) | 0 | 42 (24) | 2 (1) |
| Constipation | 11 (21) | 0 | 26 (24) | 2 (2) | 1 (17) | 0 | 0 | 0 | 38 (22) | 2 (1) |
| Abdominal pain | 10 (19) | 2 (4) | 19 (17) | 6 (6) | 0 | 0 | 0 | 0 | 29 (17) | 8 (5) |
| Anemia | 10 (19) | 7 (13) | 17 (16) | 6 (6) | 0 | 0 | 1 (25) | 0 | 28 (16) | 13 (8) |
| Diarrhea | 16 (30) | 1 (2) | 10 (9) | 0 | 1 (17) | 0 | 1 (25) | 0 | 28 (16) | 1 (1) |
| Arthralgia | 8 (15) | 0 | 17 (16) | 1 (1) | 0 | 0 | 1 (25) | 0 | 26 (15) | 1 (1) |
| Vomiting | 6 (11) | 0 | 19 (17) | 0 | 0 | 0 | 1 (25) | 0 | 26 (15) | 0 |
| Back pain | 6 (11) | 0 | 18 (17) | 3 (3) | 0 | 0 | 1 (25) | 0 | 25 (15) | 3 (2) |
| Dyspnea | 8 (15) | 2 (4) | 16 (15) | 1 (1) | 0 | 0 | 1 (25) | 0 | 25 (15) | 3 (2) |
| Peripheral edema | 8 (15) | 1 (2) | 14 (13) | 0 | 1 (17) | 0 | 2 (50) | 0 | 25 (15) | 1 (1) |
| Cough | 9 (17) | 0 | 12 (11) | 1 (1) | 0 | 0 | 0 | 0 | 21 (12) | 1 (1) |
| Myalgia | 5 (9) | 0 | 13 (12) | 0 | 1 (17) | 0 | 0 | 0 | 19 (11) | 0 |
| Pyrexia | 12 (23) | 0 | 7 (6) | 0 | 0 | 0 | 0 | 0 | 19 (11) | 0 |