Table 4.
AEs | AMG 102 10 mg/kg n = 40 | AMG 102 20 mg/kg n = 20 | All Enrolled Patients N = 60 | |||
---|---|---|---|---|---|---|
Patients with any AE, n (%) | 23 (58) | 8 (40) | 31 (52) | |||
Patients with grade ≥3 AEs,bn (%) | 4 (10) | 1 (5) | 5 (8) | |||
AEs occurring in ≥2 patients, n (%) | Any Grade | Grade 3/4 | Any Grade | Grade 3/4 | Any Grade | Grade 3/4 |
Fatigue | 9 (23) | 1 (3) | 6 (30) | 1 (5) | 15 (25) | 2 (3) |
Nausea | 5 (13) | 0 (0) | 1 (5) | 0 (0) | 6 (10) | 0 (0) |
Peripheral edemac | 4 (10) | 1 (3) | 1 (5) | 0 (0) | 5 (8) | 1 (2) |
Diarrhea | 4 (10) | 0 (0) | 0 (0) | 0 (0) | 4 (7) | 0 (0) |
Dry skin | 4 (10) | 0 (0) | 0 (0) | 0 (0) | 4 (7) | 0 (0) |
Arthralgia | 3 (8) | 0 (0) | 0 (0) | 0 (0) | 3 (5) | 0 (0) |
Hypophosphatemia | 3 (8) | 3 (8) | 0 (0) | 0 (0) | 3 (5) | 3 (5) |
Dysgeusia | 2 (5) | 0 (0) | 0 (0) | 0 (0) | 2 (3) | 0 (0) |
Hypoasthesia | 2 (5) | 0 (0) | 0 (0) | 0 (0) | 2 (3) | 0 (0) |
Edemab | 2 (5) | 1 (3) | 0 (0) | 0 (0) | 2 (3) | 1 (2) |
Asthenia | 1 (3) | 0 (0) | 1 (5) | 1 (5) | 2 (3) | 1 (2) |
Patients with any serious AE, n (%) | 1 (3) | 1 (3) | 0 (0) | 0 (0) | 1 (2) | 1 (2) |
Edema (grade 3) | 1 (3) | 1 (3) | 0 (0) | 0 (0) | 1 (2) | 1 (2) |
AE, adverse event.
aAEs are reported for patients who received ≥1 dose of AMG 102 and include all AEs for ongoing patients and AEs with onset from the first dose of AMG 102 until 30 days after the last dose of AMG 102 for patients who discontinued treatment. Partial onset dates were imputed.
bGrade 5 adverse events included disease progression (n = 9) and brain herniation (n = 1). These events were not considered by investigators to be related to treatment with AMG 102.
cThe incidence of treatment-emergent peripheral edema of any grade was greater than the incidence of treatment-related peripheral edema (23% vs 8%), and the incidence of treatment-emergent edema of any grade was greater than the incidence of treatment-related edema (7% vs 3%).