Table 3.
Treatment-emergent adverse events
| Arm I (ilorasertib PO QD) | Arm II (ilorasertib PO BID) | Arm III (ilorasertib i.v.) | Total | |
|---|---|---|---|---|
| N = 23 | N = 28 | N = 7 | N = 58 | |
| Any grade AE | 22 (96) | 27 (96) | 7 (100) | 56 (97) |
| Grade 3 or 4 | 14 (61) | 15 (54) | 3 (43) | 32 (55) |
| Any grade treatment-emergent adverse events reported in ≥10% of all patients | ||||
| Fatigue | 13 (57) | 14 (50) | 1 (14) | 28 (48) |
| Decreased appetite | 8 (35) | 9 (32) | 3 (43) | 20 (34) |
| Hypertension | 8 (35) | 9 (32) | 3 (43) | 20 (34) |
| Diarrhoea | 5 (22) | 8 (29) | 2 (29) | 15 (26) |
| Nausea | 8 (35) | 5 (18) | 2 (29) | 15 (26) |
| Constipation | 6 (26) | 5 (18) | 2 (29) | 13 (22) |
| Vomiting | 3 (13) | 8 (29) | 1 (14) | 12 (21) |
| Urinary tract infection | 2 (9) | 5 (18) | 2 (29) | 9 (16) |
| Headache | 5 (22) | 4 (14) | 0 | 9 (16) |
| Thrombocytopenia | 3 (13) | 5 (18) | 0 | 8 (14) |
| Dyspnoea | 2 (9) | 3 (11) | 2 (29) | 7 (12) |
| Hypokalaemia | 3 (13) | 3 (11) | 0 | 6 (10) |
| Hypomagnesaemia | 3 (13) | 3 (11) | 0 | 6 (10) |
| Grade 3 or 4 treatment-emergent adverse events reported in > 2% of all patients | ||||
| Hypertension | 4 (17) | 4 (14) | 2 (29) | 10 (17) |
| Diarrhoea | 1 (4) | 1 (4) | 0 | 2 (3) |
| Neutropenia | 0 | 2 (7) | 0 | 2 (3) |
AE adverse event, BID twice daily, i.v. intravenously, PO orally, QD once daily