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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.