Brief Article
Copyright ©2013 Baishideng Publishing Group Co.
World J Gastroenterol. Jun 7, 2013; 19(21): 3255-3262
Published online Jun 7, 2013. doi: 10.3748/wjg.v19.i21.3255
Table 1 Adverse events classification according to Common Terminology Criteria for Adverse Events v3.0
Adverse eventGrade 1Grade 2Grade 3Grade 4Grade 5
AnemiaHb < LLN-10.0 g/dLHb 10.0-8.0 g/dLHb < 8.0-6.5 g/dLHb < 6.5 g/dLDeath
NeutropeniaPMNPMNPMNPMNDeath
< LLN-1.5 × 109/L< 1.5-1.0 × 109/L< 1.0-0.5 × 109/L< 0.5 × 109/L
Intolerance:
FatigueMild fatigue over baselineModerate or causing difficulty performing some ADLSevere fatigue interfering with ADLDisabling
Flu-like symptomsSymptoms present but not interfering with functionModerate or causing difficulty performing some ADLSevere symptoms interfering with ADLDisablingDeath
DepressionMild mood alteration not interfering with functionModerate mood alteration interfering with function, but not interfering with ADL; medication indicatedSevere mood alteration interfering with ADLSuicidal ideation; danger to self or othersDeath
Table 2 Patients population characteristics n (%)
VariableNon-liver transplanted cirrhotic group frequency(n= 43)Liver transplanted cirrhotic group frequency(n= 17)P
Age, yr (mean ± SD)55 ± 8 (39-69)57 ± 9 (38-73)0.753
Sex0.073
Male28 (65.1)15 (88.2)
Female15 (34.9)2 (11.8)
Genotype0.750
12 (58.1)11(64.7)
213 (30.2)3 (17.6)
32 (4.7)31 (5.9)
43 (7)2 (11.8)
Previous treatment16 (37.2)4 (23.5)0.069
HCV RNA 800000 (UI/mL)15 90.198
EVR30 (69.8)8 (47.1)0.100
SVR18 (41.9)5 (29.4)0.371
Table 3 Reported liver-related and treatment-related adverse events
Non-liver transplanted cirrhoticsLiver transplanted cirrhotics
Intolerance (fatigue, flu-like symptoms, depression)
Grade 210
Grade 330
Anemia
Grade 1120
Grade 224
Grade 302
Neutropenia
Grade 202
Grade 361
Liver decompensation
Grade 1 (encephalopathy)01
Other
Hepatocellular carcinoma20
Polytrauma10