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Table 3 Treatment-emergent adverse events by Child-Pugh class at start of therapy in the safety population

From: Safety assessment of sorafenib in Chinese patients with unresectable hepatocellular carcinoma: subgroup analysis of the GIDEON study

Adverse events

Total

(N = 331)

Child-Pugh A

(n = 246)

Child-Pugh B

(n = 48)

Child-Pugh C

(n = 2)

Not evaluable

(n = 35)

Treatment-emergent AE (all grades including deaths not documented as AE)

233 (70)

175 (71)

38 (79)

0 (0)

20 (57)

AEs resulting in permanent discontinuation

29 (8.8)

22 (8.9)

5 (10)

0 (0)

2 (5.7)

Treatment-emergent AE (all grades)

167 (51)

124 (50)

27 (56)

0 (0)

16 (46)

 Grade 3–4

20 (6.0)

14 (5.7)

4 (8.3)

0 (0)

20 (6.0)

 Grade 5

73 (22)

55 (22)

11 (23)

0 (0)

7 (20)

Drug-related AE (all grades)

95 (29)

67 (27)

17 (35)

0 (0)

11 (31)

 Grade 3–4

12 (3.6)

9 (3.7)

2 (4.2)

0 (0)

1 (2.9)

 Grade 5

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

Serious AE (all grades)

77 (23)

58 (24)

12 (25)

0 (0)

7 (20)

 Drug-related (all grades)

1 (0.3)

0 (0)

1 (2.1)

0 (0)

0 (0)

All deaths

166 (50)

127 (52)

27 (56)

0 (0)

12 (34)

 Treatment-emergent death

73 (22)

55 (22)

11 (23)

0 (0)

7 (20)

  1. Data are presented as count (percentage). Percentages are presented to 2 significant figs
  2. AE adverse event, SAE serious adverse event
  3. Treatment-emergent deaths: death while on sorafenib and up to 30 days after last dose collected from all available sources
  4. All deaths: all deaths from all sources where death information was collected including follow-up information