Skip to main content

Table 2 Number of patients experiencing TEAEs leading to dose modifications (reductions, delays, or interruptions) by CTCAE grade, and occurring in > 10% of patients in any group (safety population)

From: Eribulin, Child-Pugh score, and liver-function tests: lessons from pivotal breast cancer studies 301 and 305

  Normal Liver impairment
n (%) Group A
(n = 540)
Group B
(n = 292)
Group C
(n = 440)
Group D
(n = 34)
Total 231 (42.8) 159 (54.5) 231 (52.5) 26 (76.5)
Grade 1 8 (1.5) 11 (3.8) 13 (3.0) 2 (5.9)
Grade 2 47 (8.7) 25 (8.6) 34 (7.7) 0
Grade 3 111 (20.6) 76 (26.0) 114 (25.9) 10 (29.4)
Grade 4 65 (12.0) 47 (16.1) 70 (15.9) 14 (41.2)
Neutropenia 125 (23.2) 91 (31.2) 132 (30.0) 20 (58.8)
Leucopenia 44 (8.2) 26 (8.9) 39 (8.9) 6 (17.7)
  1. Group A, no liver impairment; group B, increased AST and/or ALT only; group C, any abnormality except increased bilirubin; group D, increased bilirubin
  2. ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; TEAE, treatment-emergent adverse event