Table 3.

Adverse events reported in the safety population following treatment with PX-866

AE type reportedArm 1aN = 51, n (%)Arm 2bN = 20, n (%)Food effects N = 13, n (%)Total populationcN = 84, n (%)
 Patients with AEs50 (98.0)19 (95.0)13 (100.0)82 (97.6)
 Patients with treatment-related AEs35 (68.6)17 (85.0)12 (92.3)64 (76.2)
Treatment-related AEs by preferred term in ≥5% of patients
 Diarrhea17 (33.3)15 (75.0)9 (69.2)41 (48.8)
 Nausea18 (35.3)8 (40.0)6 (46.2)32 (38.1)
 Vomiting10 (19.6)7 (35.0)4 (30.8)21 (25.0)
 Fatigue6 (11.8)5 (25.0)3 (23.1)14 (16.7)
 Anorexia2 (3.9)4 (20.0)2 (15.4)8 (9.5)
 AST increased2 (3.9)2 (10.0)1 (7.7)5 (6.0)
 ALT increased1 (2.0)2 (10.0)1 (7.7)4 (4.8)

Abbreviation: AE, adverse event.

  • aArm 1.

  • bArm 2.

  • cArm 1, arm 2, and food effects.