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) |