Table 3.

Treatment-emergent adverse reactions occurring in ≥10% of patients by preferred term

Full analysis set (N = 129)
All gradesGrades 1–2Grades 3–4
MedDRA-preferred termN (%)N (%)N (%)
All TEAEs125 (96.9)124 (96.1)79 (61.2)
Nausea54 (41.9)53 (41.1)1 (0.8)
Fatigue48 (37.2)41 (31.8)7 (5.4)
Pyrexia45 (34.9)42 (32.6)3 (2.3)
Anemia41 (31.8)27 (20.9)14 (10.9)
Vomiting37 (28.7)36 (27.9)1 (0.8)
Constipation30 (23.3)29 (22.5)1 (0.8)
Diarrhea29 (22.5)27 (20.9)2 (1.6)
Dyspnea28 (21.7)20 (15.5)8 (6.2)
Peripheral edema26 (20.2)26 (20.2)0 (0)
Rash26 (20.2)25 (19.4)1 (0.8)
Cough24 (18.6)24 (18.6)0 (0)
Chills21 (16.3)20 (15.5)1 (0.8)
Pruritus21 (16.3)17 (13.2)4 (3.1)
Thrombocytopenia21 (16.3)12 (9.3)9 (7.0)
Increased LDH20 (15.5)18 (14.0)2 (1.6)
Decreased appetite19 (14.7)16 (12.4)3 (2.3)
Headache19 (14.7)19 (14.7)0 (0)
Infusion site pan18 (14.0)18 (14.0)0 (0)
Hypokalemia16 (12.4)11 (8.5)5 (3.9)
Abdominal pain14 (10.9)13 (10.1)1 (0.8)
QT prolongation14 (10.9)9 (7.0)5 (3.9)
Dizziness13 (10.1)13 (10.1)0 (0)
Hypotension13 (10.1)9 (7.0)4 (3.1)
Phlebitis13 (10.1)12 (9.3)1 (0.8)

Abbreviations: LDH, lactate dehydrogenase; TEAE, treatment-emergent adverse reaction.