Table 5.

Treatment-related AE that occurred in five or more enrolled patientsa

AEPatients Reporting AE (n [%])
Enrolled(n = 513)Part 1(n = 439)Part 2Part 3(n = 292)Completed(n = 226)
Cohort A(n = 215)Cohort B(n = 142)
Any AE94 (18.3)94 (21.4)45 (20.9)25 (17.6)55 (18.8)32 (14.2)
Nausea33 (6.4)33 (7.5)14 (6.5)8 (5.6)19 (6.5)5 (2.2)
Vomiting20 (3.9)20 (4.6)8 (3.7)4 (2.8)11 (3.8)5 (2.2)
Constipation10 (1.9)10 (2.3)5 (2.3)3 (2.1)6 (2.1)5 (2.2)
Diarrhea10 (1.9)10 (2.3)3 (1.4)2 (1.4)5 (1.7)3 (1.3)
Dyspepsia6 (1.2)6 (1.4)4 (1.9)2 (1.4)4 (1.4)0 (0.0)
Flatulence6 (1.2)6 (1.4)3 (1.4)2 (1.4)4 (1.4)4 (1.8)
Pruritus6 (1.2)6 (1.4)3 (1.4)1 (0.7)2 (0.7)2 (0.9)
  • a AE, adverse event.