Table 2.
Summary of all-cause TEAEs and SAEs.
| AEs | Part A (LY monotherapy) | ||||||
|---|---|---|---|---|---|---|---|
| Total Part A (N = 20) | Cohort A1 LY 4 mg/kg (n = 3) | Cohort A2 LY 8 mg/kg (n = 4) | Cohort A3 LY 12 mg/kg (n = 3) | Cohort A4 LY 16 mg/kg (n = 3) | Cohort A5 LY 20 mg/kg (n = 3) | Cohort A6 LY 27 mg/kg (n = 4) | |
| TEAEs | |||||||
| All grades | 20 (100) | 3 (100) | 4 (100) | 3 (100) | 3 (100) | 3 (100) | 4 (100) |
| Grade 3/4 | 7 (35.0) | 0 (0) | 1 (25.0) | 1 (33.3) | 1 (33.3) | 0 (0) | 4 (100) |
| Grade 5 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| SAEsa | 3 (15.0) | – | – | – | – | – | – |
| Part B (LY + RAM 8 mg/kg) | Part C (LY + RAM 12 mg/kg) | ||||||
|---|---|---|---|---|---|---|---|
| Total Part B (n = 35) | Cohort B2 LY 8 mg/kg (n = 6) | Cohort B3 LY 12 mg/kg (n = 7) | Cohort B4 LY 16 mg/kg (n = 7) | Cohort B5 LY 20 mg/kg (n = 7) | Cohort B6 LY 27 mg/kg (n = 8) | LY 20 mg/kg (n = 7) | |
| TEAEs | |||||||
| All grades | 35 (100) | 6 (100) | 7 (100) | 7 (100) | 7 (100) | 8 (100) | 7 (100) |
| Grade 3/4 | 20 (57.1) | 2 (33.3) | 5 (71.4) | 5 (71.4) | 2 (28.6) | 6 (75.0) | 6 (85.7) |
| Grade 5 | 1 (16.6) | 0 (0) | 0 (0) | 0 (0) | 1 (16.6) | 0 (0) | 0 (0) |
| SAEsa | 11 (31.4) | – | – | – | – | – | 3 (42.9) |
All data are reported as n (%), unless specified.
LY LY3127804, RAM ramucirumab.
aData not available by cohort.