Table 3 Treatment-emergent adverse events

From: Clinical pharmacodynamic/exposure characterisation of the multikinase inhibitor ilorasertib (ABT-348) in a phase 1 dose-escalation trial

  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)
  1. AE adverse event, BID twice daily, i.v. intravenously, PO orally, QD once daily