Table 2. Treatment-related adverse events.
| AMG 208 Dose Cohort (mg) | ||||||||
|---|---|---|---|---|---|---|---|---|
| All Patients (N=54) | 25 mg (n=6) | 50 mg (n=4) | 100 mg (n=4) | 150 mg (n=3) | 200 mg (n=16) | 300 mg (n=10) | 400 mg (n=11) | |
| Patients with any grade AEs, n (%) | 45 (83.3) | 2 (33.3) | 3 (75.0) | 4 (100.0) | 3 (100.0) | 14 (87.5) | 8 (80.0) | 11 (100.0) |
| Fatigue | 24 (44.4) | 2 (33.3) | 2 (50.0) | 2 (50.0) | 3 (100.0) | 3 (18.8) | 4 (40.0) | 8 (72.7) |
| Nausea | 18 (33.3) | 1 (16.7) | 2 (50.0) | 0 (0) | 1 (33.3) | 2 (12.5) | 4 (40.0) | 8 (72.7) |
| Hypertension | 12 (22.2) | 0 | 0 | 1 (25.0) | 0 | 6 (37.5) | 2 (20.0) | 3 (27.3) |
| Diarrhea | 11 (20.4) | 0 | 0 | 0 | 0 | 3 (18.8) | 2 (20.0) | 6 (54.5) |
| Anemia | 10 (18.5) | 0 | 0 | 2 (50.0) | 2 (66.7) | 4 (25.0) | 1 (10.0) | 1 (9.1) |
| Increased AST | 9 (16.7) | 0 | 0 | 0 | 2 (66.7) | 4 (25.0) | 0 | 3 (27.3) |
| Decreased appetite | 9 (16.7) | 0 | 1 (25.0) | 0 | 0 | 2 (12.5) | 3 (30.0) | 3 (27.3) |
| Leukopenia | 9 (16.7) | 0 | 0 | 0 | 3 (100.0) | 3 (18.8) | 1 (10.0) | 2 (18.2) |
| Increased ALT | 8 (14.8) | 0 | 0 | 0 | 1 (33.3) | 4 (25.0) | 0 | 3 (27.3) |
| Achromotrichia acquired | 7 (13.0) | 0 | 0 | 0 | 0 | 2 (12.5) | 2 (20.0) | 3 (27.3) |
| Thrombocytopenia | 7 (13.0) | 0 | 0 | 0 | 1 (33.3) | 2 (12.5) | 1 (10.0) | 3 (27.3) |
| Vomiting | 6 (11.1) | 0 | 1 (25.0) | 0 | 0 | 0 | 1 (10.0) | 4 (36.4) |
| Increased blood creatinine | 5 (9.3) | 0 | 0 | 0 | 1 (33.3) | 3 (18.8) | 1 (10.0) | 0 |
| Hypomagnesemia | 5 (9.3) | 0 | 0 | 1 (25.0) | 0 | 3 (18.8) | 0 | 1 (9.1) |
| Patients with grade ≥3 AEs, n (%) | 13 (24.1) | 0 | 0 | 1 (25.0) | 0 | 3 (18.8) | 3 (30.0) | 6 (54.5) |
| Anemia | 3 (5.6) | 0 | 0 | 1 (25.0) | 0 | 1 (6.3) | 1 (10.0) | 0 |
| Hypertension | 2 (3.7) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) |
| Prolonged electrocardiogram QT | 2 (3.7) | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 1 (9.1) |
| Thrombocytopenia | 2 (3.7) | 0 | 0 | 0 | 0 | 1 (6.3) | 0 | 1 (9.1) |
| Acute myocardial infarction | 1 (1.9) | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 0 |
| Increased AST | 1 (1.9) | 0 | 0 | 0 | 0 | 1 (6.3) | 0 | 0 |
| Increased blood creatinine | 1 (1.9) | 0 | 0 | 0 | 0 | 1 (6.3) | 0 | 0 |
| Increased blood creatinine phosphokinase | 1 (1.9) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) |
| Hyperglycemia | 1 (1.9) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) |
| Neutropenia | 1 (1.9) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) |
| Decreased neutrophil count | 1 (1.9) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) |
| Pulmonary embolism | 1 (1.9) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) |
Any grade treatment-related AEs occurring in ≥5 patients overall and any grade ≥3 treatment-related AEs are shown. AEs were coded using MedDRA version 15.0. AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase.