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Table 3 Summary of AEs

From: A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection

  SVR at LPVPS
N = 200
No SVR at LPVPS
N = 49
Total
N = 249
36-month study period
Any AE, n (%) 10 (5.0) 1 (2.0) 11 (4.4)
 Worst Grade 1 or 2 2 (1.0) 1 (2.0) 3 (1.2)
 Worst Grade 3 or 4 8 (4.0) 0 8 (3.2)
Any SAE, n (%) 10 (5.0) 0 10 (4.0)
 SAE at least possibly related to the study drug 0 0 0
Any AE with a fatal outcome, n (%) 3 (1.5)a 0 3 (1.2)a
AE for which study procedure was permanently stopped, n (%) 1 (0.5)b 0 1 (0.4)b
AE of hepatocellular carcinoma type, n (%) 3 (1.5) 0 3 (1.2)
Patients on disallowed medication c n = 0 n = 8 n = 8
Any AE, n (%)
 Worst Grade 1 or 2 0 1 (12.5) 1 (12.5)
 Worst Grade 3 or 4 0 1 (12.5) 1 (12.5)
Any SAE, n (%) 0 1 (12.5) 1 (12.5)
 SAE at least possibly related to the study drug 0 0 0
Any AE with a fatal outcome, n (%) 0 0 0
AE for which study procedure was permanently stopped, n (%) 0 0 0
AE of hepatocellular carcinoma type, n (%) 0 1 (12.5) 1 (12.5)
  1. AE adverse event, HCV hepatitis C virus, LPVPS last post-therapy follow-up visit of the parent study, SAE serious adverse event, SVR sustained virologic response
  2. aGrade 4 cholangitis and pancreatic carcinoma, Grade 3 hepatic neoplasm malignant and Grade 4 myocardial infarction
  3. bGrade 3 hepatic neoplasm malignant
  4. cAEs reported for patients who started disallowed HCV medication are presented separately from the time this medication was started