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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
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Breast Cancer Research

ISSN: 1465-542X

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