Table 2.
Patient incidence of adverse events in the AMG 232 dose escalation
| AMG 232 Dose Escalation Cohort | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 15 mg (n = 3) | 30 mg (n = 3) | 60 mg (n = 4) | 120 mg (n = 7) | 240 mg (n = 8) | 300 mg (n = 4) | 360 mg (n = 4) | 480 mg (n = 6) | Total (n = 39) | |
| Patients with any treatment-emergent AE, n (%) | 1 (33) | 3 (100) | 4 (100) | 7 (100) | 8 (100) | 4 (100) | 4 (100) | 6 (100) | 37 (95) |
| Patients with any treatment-emergent serious AE, n (%) | 1 (33) | 0 | 0 | 3 (43) | 4 (50) | 2 (50) | 0 | 4 (67) | 14 (36) |
| Patients with any treatment-related AE, n (%) | 1 (33) | 1 (33) | 3 (75) | 7 (100) | 8 (100) | 4 (100) | 4 (100) | 6 (100) | 34 (87) |
| Grade 3 | 0 | 0 | 0 | 1 (14) | 3 (38) | 3 (75) | 3 (75) | 3 (50) | 13 (33) |
| Grade 4 | 0 | 0 | 0 | 1 (14) | 0 | 2 (50) | 2 (50) | 3 (50) | 8 (21) |
| Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment-related AEs occurring in ≥10% of patients, n (%) | |||||||||
| Diarrhea | 0 | 1 (33) | 1 (25) | 3 (43) | 6 (75) | 4 (100) | 4 (100) | 6 (100) | 25 (64) |
| Nausea | 0 | 1 (33) | 3 (75) | 3 (43) | 5 (63) | 1 (25) | 4 (100) | 3 (50) | 20 (51) |
| Vomiting | 0 | 1 (33) | 0 | 2 (29) | 5 (63) | 3 (75) | 3 (75) | 4 (67) | 18 (46) |
| Fatigue | 1 (33) | 1 (33) | 1 (25) | 3 (43) | 4 (50) | 2 (50) | 0 | 4 (67) | 16 (41) |
| Thrombocytopenia | 0 | 0 | 0 | 1 (14) | 1 (13) | 3 (75) | 4 (100) | 5 (83) | 14 (36) |
| Decrease appetite | 0 | 0 | 1 (25) | 2 (29) | 2 (25) | 1 (25) | 3 (75) | 1 (17) | 10 (26) |
| Neutropenia | 0 | 0 | 0 | 0 | 0 | 2 (50) | 3 (75) | 3 (50) | 8 (21) |
| Anemia | 0 | 0 | 0 | 0 | 1 (13) | 0 | 2 (50) | 2 (33) | 5 (13) |
| Myalgia | 0 | 0 | 0 | 1 (14) | 0 | 0 | 2 (50) | 1 (17) | 4 (10) |
| Asthenia | 0 | 0 | 0 | 0 | 1 (13) | 1 (25) | 2 (50) | 0 | 4 (10) |
| Abdominal pain | 0 | 0 | 0 | 0 | 2 (25) | 1 (25) | 1 (25) | 0 | 4 (10) |
| Dysgeusia | 0 | 0 | 0 | 0 | 2 (25) | 1 (25) | 1 (25) | 0 | 4 (10) |
| Upper abdominal pain | 0 | 0 | 0 | 1 (14) | 1 (13) | 1 (25) | 1 (25) | 0 | 4 (10) |
| Patients with any treatment-related serious AE, n (%) | 0 | 0 | 0 | 0 | 2 (25) | 2 (50) | 0 | 2 (33) | 6 (15) |
| Vomiting | 0 | 0 | 0 | 0 | 1 (13) | 2 (50) | 0 | 0 | 3 (8) |
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 1 (3) |
| Grade 3 | 0 | 0 | 0 | 0 | 1 (13) | 1 (25) | 0 | 0 | 2 (5) |
| Diarrhea | 0 | 0 | 0 | 0 | 1 (13) | 1 (25) | 0 | 0 | 2 (5) |
| Grade 2 | 0 | 0 | 0 | 0 | 1 (13) | 0 | 0 | 0 | 1 (3) |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 1 (3) |
| Thrombocytopenia (grade 4) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (33) | 2 (5) |
| Hematemesis (grade 3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 1 (3) |
| Neutropenia (grade 4) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 1 (3) |
| Dehydration (grade 2) | 0 | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 1 (3) |
| Febrile neutropenia (grade 3) | 0 | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 1 (3) |
| Abdominal pain (grade 2) | 0 | 0 | 0 | 0 | 1 (13) | 0 | 0 | 0 | 1 (3) |
| Nausea (grade 3) | 0 | 0 | 0 | 0 | 1 (13) | 0 | 0 | 0 | 1 (3) |
| Non-cardiac chest pain (grade 3) | 0 | 0 | 0 | 0 | 1 (13) | 0 | 0 | 0 | 1 (3) |
AE, adverse event