Table 3 Grade 3/4 AEs reported in more than five patients.
Dose-escalation cohorts, N (%) | RP2D-expansion cohorts, N (%) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5A | 5B | H | B | C | O | U | ||
Patient characteristics | N = 3 | N = 6 | N = 5 | N = 3 | N = 2 | N = 4 | N = 22 | N = 9 | N = 16 | N = 20 | N = 9 | All patients, N (%) |
Any grade 3/4 AE (highest severity) | 2 (67) | 4 (67) | 4 (80) | 2 (67) | 2 (100) | 3 (75) | 16 (73) | 8 (89) | 11 (69) | 16 (80) | 7 (78) | 75 (76) |
Neutropenia | 0 | 1 (17) | 1 (20) | 1 (33) | 2 (100) | 3 (75) | 2 (9) | 2 (22) | 6 (38) | 11 (55) | 3 (33) | 32 (32) |
Leukopenia | 0 | 0 | 1 (20) | 0 | 2 (100) | 1 (25) | 2 (9) | 2 (22) | 1 (6) | 6 (30) | 2 (22) | 17 (17) |
Anemia | 1 (33) | 0 | 1 (20) | 0 | 0 | 0 | 5 (23) | 2 (22) | 3 (19) | 2 (10) | 0 | 14 (14) |
Thrombocytopenia | 1 (33) | 1 (17) | 2 (40) | 0 | 2 (100) | 0 | 0 | 2 (22) | 1 (6) | 2 (10) | 0 | 11 (11) |
Hyponatremia | 0 | 0 | 0 | 1 (33) | 1 (50) | 0 | 1 (5) | 1 (11) | 2 (13) | 2 (10) | 1 (11) | 9 (9) |
Decreased neutrophil count | 0 | 0 | 0 | 0 | 0 | 0 | 5 (23) | 4 (44) | 0 | 0 | 0 | 9 (9) |
Fatigue | 0 | 1 (17) | 2 (40) | 0 | 0 | 0 | 0 | 0 | 3 (19) | 1 (5) | 0 | 7 (7) |
Dyspnea | 0 | 0 | 1 (20) | 0 | 1 (50) | 0 | 1 (5) | 0 | 0 | 2 (10) | 1 (11) | 6 (6) |
