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Table 6 Adverse events in all randomized subjects

From: One-year treatment with mometasone furoate in chronic obstructive pulmonary disease

  MF-DPI 800 μg QD PM (n = 308) MF-DPI 400 μg BID (n = 308) Placebo (n = 295)
Any adverse event, n (%) 224 (73) 228 (74) 204 (69)
URTI, n (%) 82 (27) 82 (27) 71 (24)
Oral candidiasis, n (%) 34 (11) 30 (10) 10 (3)
Pharyngitis, n (%) 26 (8) 28 (9) 24 (8)
Bruise/bruising*, n (%) 46 (15) 45 (14) 33 (11)
New forearm bruising, n (%) 27 (10) 27 (10) 21 (7)
Back pain, n (%) 23 (7) 15 (5) 10 (3)
COPD aggravated, n (%) 11 (4) 12 (4) 14 (5)
Pneumonia, n (%) 12 (4) 13 (4) 6 (2)
  1. BID = twice daily; COPD = chronic obstructive pulmonary disease; MF-DPI = mometasone furoate administered via a dry powder inhaler; URTI = upper respiratory tract infection.
  2. *Either adverse event, which have different reporting codes, could be reported.
  3. †Visual forearm inspection completed at each visit. New forearm bruises = 5 cm in diameter were captured in a separate module of the case report form. All new bruises, regardless of size and location, were captured in the adverse event module.