Table 5.

Summary of AEs (safety population)

Description of AEEPPIC-1 (n=1016)EPPIC-2 (n=1012)Pooled (n=1028)
AST-120 (n=507)Placebo (n=509)AST-120 (n=507)Placebo (n=505)AST-120 (n=1014)Placebo (n=1014)
EventsPatientsEventsPatientsEventsPatientsEventsPatientsEventsPatientsEventsPatients
Treatment-emergent AE2483436 (86.0)2589448 (88.0)2727438 (86.4)2488425 (84.2)5210874 (86.2)5077873 (86.1)
 Severe193105 (20.7)18594 (18.5)227104 (20.5)233110 (21.8)420209 (20.6)418204 (20.1)
 Moderate854210 (41.4)925214 (42.0)967208 (41.0)874201 (39.8)1821418 (41.2)1799415 (40.9)
 Mild1435121 (23.9)1476140 (27.5)1533126 (24.9)1381114 (22.6)2968247 (24.4)2857254 (25.0)
 Unknowna103000001030
Treatment-related AE14293 (18.3)14794 (18.5)203109 (21.5)203106 (21.0)345202 (19.9)350200 (19.7)
Treatment-related AEs occurring in ≥1% of patients in either treatment group
 Gastrointestinal disorders10372 (14.2)10172 (14.1)14689 (17.6)14289 (17.6)249161 (15.9)243161 (15.9)
  Constipation2525 (4.9)2221 (4.1)2925 (4.9)2119 (3.8)5450 (4.9)4340 (3.9)
  Nausea1413 (2.6)1313 (2.6)1918 (3.6)1212 (2.4)3331 (3.1)2525 (2.5)
  Diarrhea1312 (2.4)119 (1.8)2217 (3.4)2218 (3.6)3529 (2.9)3327 (2.7)
  Abdominal distention1010 (2.0)108 (1.6)1414 (2.8)1212 (2.4)2424 (2.4)2220 (2.0)
  Flatulence77 (1.4)1212 (2.4)1010 (2.0)1514 (2.8)1717 (1.7)2726 (2.6)
  Vomiting33 (0.6)43 (0.6)108 (1.6)98 (1.6)1311 (1.1)1311 (1.1)
  Abdominal pain76 (1.2)65 (1.0)106 (1.2)55 (1.0)1712 (1.2)1110 (1.0)
  Abdominal discomfort33 (0.6)0077 (1.4)001010 (1.0)00
  Dyspepsia55 (1.0)55 (1.0)22 (0.4)98 (1.6)77 (0.7)1413 (1.3)
  Stool discolored11 (0.2)44 (0.8)33 (0.6)1010 (2.0)44 (0.4)1414 (1.4)
  Gastritis0011 (0.2)33 (0.6)1310 (2.0)33 (0.3)1411 (1.1)
 Metabolism and nutrition disorders77 (1.4)1010 (2.0)54 (0.8)1010 (2.0)1211 (1.1)2020 (2.0)
  Decreased appetite11 (0.2)55 (1.0)32 (0.4)66 (1.2)43 (0.3)1111 (1.1)
 Skin and subcutaneous tissue disorders88 (1.6)54 (0.8)1311 (2.2)1110 (2.0)2119 (1.9)1614 (1.4)
  Pruritus11 (0.2)22 (0.4)86 (1.2)66 (1.2)97 (0.7)88 (0.8)
Treatment-emergent SAE370195 (38.5)375184 (36.1)343156 (30.8)363178 (35.2)713351 (34.6)738362 (35.7)
Treatment-related SAE65 (1.0)33 (0.6)84 (0.8)85 (1.0)149 (0.9)118 (0.8)
Treatment-emergent AE leading to discontinuation of study drug9369 (13.6)6452 (10.2)6043 (8.5)9261 (12.1)153112 (11.0)156113 (11.1)
Treatment-related AE leading to discontinuation of study drug2013 (2.6)1715 (2.9)1511 (2.2)1916 (3.2)3524 (2.4)3631 (3.1)
Death due to treatment-emergent AE2823 (4.5)1715 (2.9)3127 (5.3)4437 (7.3)5950 (4.9)6152 (5.1)
  • Data are presented as n or n (%). Treatment-emergent AE/SAEs are AEs/SAEs with onset dates on or after the start of study drug. Treatment-related AE/SAEs are any treatment-emergent AE/SAE in which the relationship to drug was possible, probable, or definite. The safety population included all randomly assigned patients who received ≥1 dose of study drug. SAE, serious adverse event.

  • a Each patient who experienced a treatment-emergent AE of unknown status experienced multiple treatment-emergent AEs of another status (severe, moderate, or mild).