Table 2 Common treatment-related TEAEs (all grades) reported in ≥10% of patients by dosing schedule.
Preferred term | Dose (QD), n (%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
1, 2, 3.5, & 5 mg | 7 mg | 10 mg | 12 mg | 14 mg | 20 mg | 30 mg | 40 mg | Total | |
Schedule I | N = 25 | N = 14 | N = 7 | N = 0 | N = 5 | N = 4 | N = 4 | N = 6 | N = 65 |
Any TEAE | 19 (76) | 11 (79) | 3 (43) | – | 5 (100) | 3 (75) | 4 (100) | 5 (83) | 50 (77) |
Diarrhea | 7 (28) | 4 (29) | 2 (29) | – | 5 (100) | 1 (25) | 3 (75) | 5 (83) | 27 (42) |
Nausea | 3 (12) | 4 (29) | 2 (29) | – | 1 (20) | 2 (50) | 3 (75) | 3 (50) | 18 (28) |
Fatigue | 3 (12) | 2 (14) | 1 (14) | – | 0 | 2 (50) | 1 (25) | 2 (33) | 11 (17) |
Vomiting | 1 (4) | 2 (14) | 2 (29) | – | 1 (20) | 0 | 0 | 3 (50) | 9 (14) |
Schedule II | N = 0 | N = 5 | N = 0 | N = 5 | N = 5 | N = 4 | N = 0 | N = 0 | N = 19 |
|---|---|---|---|---|---|---|---|---|---|
Any TEAE | – | 1 (20) | – | 4 (80) | 4 (80) | 4 (100) | – | – | 13 (68) |
Diarrhea | – | 1 (20) | – | 1 (20) | 2 (40) | 4 (100) | – | – | 8 (42) |
Vomiting | – | 0 | – | 0 | 1 (20) | 3 (75) | – | – | 4 (21) |
ECG QTcF prolonged | – | 0 | – | 0 | 1 (20) | 2 (50) | – | – | 3 (16) |
Nausea | – | 0 | – | 1 (20) | 0 | 2 (50) | – | – | 3 (16) |
Dysgeusia | – | 0 | – | 1 (20) | 0 | 1 (25) | – | – | 2 (11) |
Fatigue | – | 0 | – | 1 (20) | 0 | 1 (25) | – | – | 2 (11) |
Hypophosphatemia | – | 0 | – | 2 (40) | 0 | 0 | – | – | 2 (11) |
