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. 2012 May 23;75(1):136–145. doi: 10.1111/j.1365-2125.2012.04339.x

Table 3.

Adverse events with avagacestat or placebo

Events, n Placebo Avagacestat Placebo Avagacestat Total placebo (n= 9) Total Avagacestat (n= 27)
18–59 years (n= 4) 18–45 years (n= 6) 46–59 years (n= 6) ≥60 years (n= 5) 60–74 years (n= 6) ≥75 years (n= 9)
Total subjects with AEs 1 2 1 4 3 6 5 12
Total AEs 2 2 1 9 4 6 11 13
System organ class preferred term
General disorders and administration site conditions 0 0 0 0 0 1 0 0
Gastrointestinal disorders
  Constipation 0 0 0 0 0 1 0 1
Infections and infestations 0 0 0 1 0 1 1 1
Investigations (increases in ALT, AST, blood CPK and LDH, and transaminases); occult blood positive 2 2 0 0 0 0 2 2
Muscoskeletal and connective tissue disorders 0 0 0 0 0 1 0 1
Nervous system disorders
  Dizziness 0 0 1 2 1 0 2 2
  Headache 0 0 0 0 0 1 0 1
  Haemorrhagic stroke 0 0 0 1 0 0 1 0
  Paresthesia 0 0 0 1 0 0 1 0
Renal and urinary disorders 0 0 0 1 1 0 1 1
Skin and subcutaneous tissue disorders 0 0 0 1 0 0 1 0
Unspecified 0 0 0 0 0 1 0 1
Vascular disorders 0 0 0 2 2 0 2 2

AEs, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; LDH, lactate dehydrogenase.