Summary of TRAEs
| AMG 404 240 mg (n=3) | AMG 404 480 mg (n=144) | AMG 404 1050 mg (n=21) | All dose cohorts (n=168) | |
| All TRAEs | 1 (33.3) | 93 (64.6) | 15 (71.4) | 109 (64.9) |
| Grade 1 | 1 (33.3) | 36 (25.0) | 4 (19.0) | 41 (24.4) |
| Grade 2 | 0 | 40 (27.8) | 11 (52.4) | 51 (30.4) |
| Grade 3 | 0 | 16 (11.1) | 0 | 16 (9.5) |
| Grade 4 | 0 | 0 | 0 | 0 |
| Fatal | 0 | 1 (0.7) | 0 | 1 (0.6) |
| Serious | 0 | 12 (8.3) | 0 | 12 (7.1) |
| Leading to discontinuation of AMG 404 | 0 | 5 (3.5) | 0 | 5 (3.0) |
| TRAEs in ≥5% of patients in any cohort | ||||
| Fatigue | 0 | 21 (14.6) | 6 (28.6) | 27 (16.1) |
| Pruritus | 1 (33.3) | 14 (9.7) | 3 (14.3) | 18 (10.7) |
| Hypothyroidism | 0 | 13 (9.0) | 3 (14.3) | 16 (9.5) |
| Nausea | 0 | 13 (9.0) | 2 (9.5) | 15 (8.9) |
| Decreased appetite | 0 | 12 (8.3) | 1 (4.8) | 13 (7.7) |
| Pyrexia | 0 | 11 (7.6) | 1 (4.8) | 12 (7.1) |
| Diarrhoea | 0 | 9 (6.3) | 1 (4.8) | 10 (6.0) |
| Rash | 0 | 9 (6.3) | 1 (4.8) | 10 (6.0) |
| Arthralgia | 0 | 7 (4.9) | 2 (9.5) | 9 (5.4) |
| AST increased | 0 | 8 (5.6) | 0 | 8 (4.8) |
| Hyperthyroidism | 0 | 8 (5.6) | 0 | 8 (4.8) |
Data are presented as number (%) of patients.
The safety analysis set comprised all patients who received ≥1 dose of AMG 404.
The highest (or worst) grade is summarised.
One patient in the AMG 404 240 mg cohort had intrapatient dose escalation to 480 mg after cycle 4.
An AE was defined as starting on or after the first administration of AMG 404 and up to and including 140 days after the last dose for AMG 404, or end of the study, whichever occurred earlier.
For patients with multiple events under the same category, only the worst grade is reported.
One AE with unknown/missing relatedness to AMG 404 was assumed as an event related to AMG 404.
AEs were coded using MedDRA V.25.0. AEs were graded using CTCAE V.5.0.
AE, adverse event; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; MedDRA, Medical Dictionary for Regulatory Activities; TRAE, treatment-related AE.