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Table 3 AEs possibly related to nilotinib, occurring in more than one patient and all SAEs

From: A proof-of-concept study with the tyrosine kinase inhibitor nilotinib in spondyloarthritis

  Nilotinib (n = 13) Placebo/nilotinib (n = 15)
Week 0–24 Week 0–12 Week 12–24
Number of patients with AEs 13 (100.0) 14 (93.3) 13 (86.7)
 Infections
  Common cold 5 (38.5) 4 (26.7) 4 (26.7)
  Gastroenteritis 4 (30.8) 2 (13.3) 1 (6.7)
  Sinusitis 2 (15.4) 0 (0.0) 0 (0.0)
 Dermatological
  Rash/acne 8 (61.5) 2 (13.3) 6 (40.0)
  Hair loss 3 (23.1) 2 (13.3) 2 (13.3)
  Mastopathy 2 (15.4) 0 (0.0) 1 (6.7)
 Gastrointestinal
  Stomach ache 5 (38.5) 3 (20.0) 1 (6.7)
  Nausea 5 (38.5) 3 (20.0) 6 (40.0)
  Anorexia 2 (15.4) 3 (20.0) 2 (13.3)
  Weight loss 2 (15.4) 1 (6.7) 1 (6.7)
  Constipation 3 (23.1) 1 (6.7) 0 (0.0)
 Cardiological
  Palpitations 1 (7.7) 0 (0.0) 2 (13.3)
 Musculoskeletal
  Myalgia 3 (23.1) 0 (0.0) 2 (13.3)
  Peripheral edema 2 (15.4) 1 (6.7) 0 (0.0)
  Flank pain 3 (23.1) 0 (0.0) 0 (0.0)
 Neurological
  Headache 5 (38.5) 1 (6.7) 2 (13.3)
 Ear/nose/throat
  Cough 0 (0.0) 0 (0.0) 2 (13.3)
 Psychological
  Depressive feelings 2 (15.4) 0 (0.0) 0 (0.0)
 Other
  General malaise 1 (7.7) 0 (0.0) 1 (6.7)
  Tiredness 3 (23.1) 1 (6.7) 2 (13.3)
  Hot flushes 1 (7.7) 0 (0.0) 2 (13.3)
  Sicca 0 (0.0) 1 (6.7) 2 (13.3)
Number of patients with SAEs 1 (7.7) 0 (0.0) 0 (0.0)
 Hospital admission 1 (7.7) 0 (0.0) 0 (0.0)
  1. Values are the number (percentage) of patients. The SAE concerned one case of hospital admission following laparoscopic surgery because of acute cholecystitis. The placebo/nilotinib treated patients received placebo from week 0 until week 12, and nilotinib from week 12 until week 24
  2. AE adverse event; SAE serious adverse event