Table 2.
Most common treatment-emergent adverse events (safety population)
| TEAEs | Dose escalation phase | Dose expansion phase | ||||||
|---|---|---|---|---|---|---|---|---|
| Regardless of attribution | Drug-relateda | Regardless of attribution | Drug-relateda | |||||
| Q2D, n = 30 | QW, n = 20 | Total, n = 50 | Total, n = 50 | Q2D, n = 80 | QW, n = 19 | Total, n = 99 | Total, n = 99 | |
| Any | 30 (100) | 20 (100) | 50 (100) | 43 (86) | 80 (100) | 19 (100) | 99 (100) | 89 (90) |
| ≥ Grade 3 | 13 (43) | 15 (75) | 28 (56) | 11 (22) | 58 (73) | 9 (47) | 67 (68) | 38 (38) |
| Preferred term (any grade) | ||||||||
| Fatigue | 20 (67) | 11 (55) | 31 (62) | 24 (48) | 34 (43) | 9 (47) | 43 (43) | 32 (32) |
| Anemia | 8 (27) | 8 (40) | 16 (32) | 11 (22) | 33 (41) | 4 (21) | 37 (37) | 24 (24) |
| Constipation | 9 (30) | 4 (20) | 13 (26) | 5 (10) | 30 (38) | 4 (21) | 34 (34) | 15 (15) |
| Nausea | 5 (17) | 7 (35) | 12 (24) | 6 (12) | 29 (36) | 5 (26) | 34 (34) | 18 (18) |
| Rash maculo-papular | 11 (37) | 2 (10) | 13 (26) | 13 (26) | 30 (38) | 3 (16) | 33 (33) | 32 (32) |
| Myalgia | 6 (20) | 5 (25) | 11 (22) | 10 (20) | 20 (25) | 3 (16) | 23 (23) | 17 (17) |
| Dyspnea | 3 (10) | 4 (20) | 7 (14) | 1 (2) | 24 (30) | 4 (21) | 28 (28) | 7 (7) |
| Arthralgia | 9 (30) | 4 (20) | 13 (26) | 10 (20) | 11 (14) | 4 (21) | 15 (15) | 9 (9) |
| Vomiting | 3 (10) | 5 (25) | 8 (16) | 5 (10) | 16 (20) | 3 (16) | 19 (19) | 11 (11) |
| Edema peripheral | 7 (23) | 3 (15) | 10 (20) | 2 (4) | 15 (19) | 0 | 15 (15) | 4 (4) |
| Blood creatine phosphokinase increased | 0 | 0 | 0 | 0 | 23 (29) | 1 (5) | 24 (24) | 21 (21) |
| Pruritus | 4 (13) | 3 (15) | 7 (14) | 6 (12) | 16 (20) | 1 (5) | 17 (17) | 15 (15) |
| Decreased appetite | 3 (10) | 2 (10) | 5 (10) | 2 (4) | 14 (18) | 4 (21) | 18 (18) | 10 (10) |
| Diarrhea | 6 (20) | 3 (15) | 9 (18) | 6 (12) | 13 (16) | 1 (5) | 14 (14) | 3 (3) |
| Headache | 3 (10) | 6 (30) | 9 (18) | 4 (8) | 11 (14) | 2 (11) | 13 (13) | 5 (5) |
| Periorbital edema | 4 (13) | 1 (5) | 5 (10) | 4 (8) | 14 (18) | 2 (11) | 16 (16) | 16 (16) |
| Pyrexia | 2 (7) | 2 (10) | 4 (8) | 0 | 14 (18) | 3 (16) | 17 (17) | 7 (7) |
| Dysgeusia | 2 (7) | 0 | 2 (4) | 2 (4) | 16 (20) | 1 (5) | 17 (17) | 13 (13) |
| Abdominal pain | 3 (10) | 5 (25) | 8 (16) | 0 | 9 (11) | 1 (5) | 10 (10) | 2 (2) |
| Dermatitis acneiform | 4 (13) | 0 | 4 (8) | 4 (8) | 12 (15) | 2 (11) | 14 (14) | 13 (13) |
| Pain in extremity | 1 (3) | 2 (10) | 3 (6) | 1 (2) | 14 (18) | 0 | 14 (14) | 3 (3) |
| Aspartate aminotransferase increased | 0 | 0 | 0 | 0 | 16 (20) | 0 | 16 (16) | 10 (10) |
| Back pain | 1 (3) | 2 (10) | 3 (6) | 1 (2) | 12 (15) | 1 (5) | 13 (13) | 0 |
| Cough | 3 (10) | 1 (5) | 4 (8) | 0 | 10 (13) | 2 (11) | 12 (12) | 0 |
| Hair color changes | 2 (7) | 0 | 2 (4) | 1 (2) | 13 (16) | 1 (5) | 14 (14) | 12 (12) |
| Face edema | 6 (20) | 2 (10) | 8 (16) | 7 (14) | 7 (9) | 0 | 7 (7) | 6 (6) |
Data are n (%). Treatment emergent adverse events shown are those occurring in ≥ 10% of the overall safety population regardless of attribution. The proportion of those events assessed as drug-related is also summarized
CI confidence interval, Q2D once every other day, QW once weekly
aDeemed by the site investigator to have had a reasonable possibility of being caused by the study drug