Treatment-related adverse events captured in greater than 10% of patients per cohort
Adverse event, n (%)∗ . | Phase 2 and Exp (n = 60) . | Phase 1b (n = 17) . | ||||
---|---|---|---|---|---|---|
Grade . | 1/2 . | 3+ . | All . | 1/2 . | 3+ . | All . |
Neutropenia | 0 (0) | 4 (6.7) | 4 (6.7) | 0 (0) | 7 (41.2) | 7 (41.2) |
Anemia | 1 (1.7) | 2 (3.3) | 3 (5) | 2 (11.8) | 1 (5.9) | 3 (17.6) |
Thrombocytopenia | 0 (0) | 3 (5) | 3 (5) | 2 (11.8) | 3 (17.6) | 5 (29.4) |
Leukopenia | 1 (1.7) | 1 (1.7) | 2 (3.3) | 1 (5.9) | 5 (29.4) | 6 (35.3) |
Lymphopenia | 0 (0) | 1 (1.7) | 1 (1.7) | 1 (5.9) | 3 (17.6) | 4 (23.5) |
Nausea | 21 (35) | 0 (0) | 21 (35) | 3 (17.6) | 2 (11.8) | 5 (29.4) |
Diarrhea | 13 (21.7) | 0 (0) | 13 (21.7) | 2 (11.8) | 1 (5.9) | 3 (17.6) |
Vomiting | 6 (10) | 0 (0) | 6 (10) | 3 (17.6) | 1 (5.9) | 4 (23.5) |
Blood bilirubin increased | 23 (38.3) | 1 (1.7) | 24 (40) | 7 (41.2) | 2 (11.8) | 9 (52.9) |
Decreased appetite | 11 (18.3) | 1 (1.7) | 12 (20) | 2 (11.8) | 0 (0) | 2 (11.8) |
Differentiation syndrome | 1 (1.7) | 12 (20) | 13 (21.7) | 0 (0) | 2 (11.8) | 2 (11.8) |
Adverse event, n (%)∗ . | Phase 2 and Exp (n = 60) . | Phase 1b (n = 17) . | ||||
---|---|---|---|---|---|---|
Grade . | 1/2 . | 3+ . | All . | 1/2 . | 3+ . | All . |
Neutropenia | 0 (0) | 4 (6.7) | 4 (6.7) | 0 (0) | 7 (41.2) | 7 (41.2) |
Anemia | 1 (1.7) | 2 (3.3) | 3 (5) | 2 (11.8) | 1 (5.9) | 3 (17.6) |
Thrombocytopenia | 0 (0) | 3 (5) | 3 (5) | 2 (11.8) | 3 (17.6) | 5 (29.4) |
Leukopenia | 1 (1.7) | 1 (1.7) | 2 (3.3) | 1 (5.9) | 5 (29.4) | 6 (35.3) |
Lymphopenia | 0 (0) | 1 (1.7) | 1 (1.7) | 1 (5.9) | 3 (17.6) | 4 (23.5) |
Nausea | 21 (35) | 0 (0) | 21 (35) | 3 (17.6) | 2 (11.8) | 5 (29.4) |
Diarrhea | 13 (21.7) | 0 (0) | 13 (21.7) | 2 (11.8) | 1 (5.9) | 3 (17.6) |
Vomiting | 6 (10) | 0 (0) | 6 (10) | 3 (17.6) | 1 (5.9) | 4 (23.5) |
Blood bilirubin increased | 23 (38.3) | 1 (1.7) | 24 (40) | 7 (41.2) | 2 (11.8) | 9 (52.9) |
Decreased appetite | 11 (18.3) | 1 (1.7) | 12 (20) | 2 (11.8) | 0 (0) | 2 (11.8) |
Differentiation syndrome | 1 (1.7) | 12 (20) | 13 (21.7) | 0 (0) | 2 (11.8) | 2 (11.8) |
Only the worst grade of the same adverse event was counted for the same patient.