Table 2

Adverse events occurring in ≥2 patients in placebo or PF-00547,659 combined groups (single- and multiple-dose study phases combined)

System organ class/preferred termPercentage of patients with all-cause (treatment-related) adverse events
Placebo (N=20)PF-00547,659 (N=60)
Any adverse event75 (20)82 (37)
Severe adverse events10 (0)13 (5)
Headache10 (5)30 (13)
Abdominal pain*25 (0)20 (0)
Worsening of ulcerative colitis15 (0)13 (0)
Fatigue10 (10)13 (5)
Arthralgia10 (0)10 (3)
Influenza/influenza-like illness0 (0)10 (2)
Gastroenteritis/enteritis5 (0)8 (0)
Anaemia0 (0)8 (2)
Nasopharyngitis10 (0)7 (2)
Respiratory tract infection0 (0)7 (2)
Nausea10 (0)5 (3)
Dizziness5 (0)5 (3)
Peripheral oedema0 (0)5 (2)
Back pain15 (0)3 (0)
Vomiting5 (0)3 (0)
Erythema5 (5)3 (0)
Insomnia (initial)0 (0)3 (3)
Eczema0 (0)3 (3)
Pruritis0 (0)3 (3)
Hot flush0 (0)3 (3)
Pain (not otherwise specified)0 (0)3 (0)
  • * Includes preferred terms abdominal pain, upper abdominal pain and lower abdominal pain.

  • Includes preferred terms anaemia and iron deficiency anaemia.

  • Includes preferred terms respiratory tract infection and upper respiratory tract infection.