Table 2.

TEAEs possibly related to study drug (all gradesa that occurred in ≥10% of patients)

Part APart BPart CTotal (Parts A–C)Part DAll parts
(N = 54)(N = 18)(N = 8)N = 80(N = 9)(N = 89)
All gradesGr ≥3All gradesGr ≥3All gradesGr ≥3All gradesGr ≥3All gradesGr ≥3All gradesGr ≥3
TEAEsn (%)n (%)n (%)n (%)n (%)n (%)n (%)n (%)n (%)n (%)n (%)n (%)
 Rash8 (14.8)1 (1.9)8 (44.4)4 (22.2)2 (25.0)2 (25.0)18 (22.5)7 (8.8)5 (55.6)1 (11.1)23 (25.8)8 (8.9)
 Fatigue11 (20.4)1 (1.9)4 (22.2)2 (25.0)17 (21.3)1 (1.3)5 (55.6)22 (24.7)1 (1.1)
 Nausea10 (18.5)4 (22.2)14 (17.5)2 (22.2)16 (18.0)0
 Constipation8 (14.8)4 (22.2)1 (12.5)13 (16.3)3 (33.3)16 (18.0)0
 Pruritus5 (9.3)4 (22.2)1 (5.6)9 (11.3)1 (1.3)4 (44.4)13 (14.6)1 (1.1)
 Vomiting8 (14.8)4 (22.2)12 (15.0)1 (11.1)13 (14.6)0
 Anorexia5 (9.3)5 (27.8)10 (12.5)10 (11.2)0
 Tremor4 (7.4)4 (22.2)1 (12.5)9 (11.3)1 (11.1)10 (11.2)0
 Dizziness3 (5.6)4 (22.2)1 (12.5)8 (10.0)1 (11.1)9 (10.1)0

Abbreviation: Gr, grade.

  • aGrades are according to Common Terminology Criteria for Adverse Events, version 3.0.