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Table 4 AESI occurring in any treatment groups (integrated clinical studies)

From: Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma

AE of special interest (preferred term), n a (%) Placebo
(n = 858)
FF 50 μg OD
(n = 338)
FF 100 μg OD
(n = 1663)
FF 200 μg OD
(n = 608)
FP 100 μg BD
(n = 217)
FP 250 μg BD
(n = 214)
FP 500 μg BD
(n = 305)
Local steroid effects 15 (2) 7 (2) 122 (7) 48 (8) 8 (4) 18 (8) 25 (8)
 Oropharyngeal pain 11 (1) 2 (<1) 71 (4) 19 (3) 4 (2) 6 (3) 11 (4)
 Dysphonia 4 (<1) 1 (<1) 23 (1) 11 (2) 3 (1) 6 (3) 6 (2)
 Oral candidiasis 0 4 (1) 18 (1) 8 (1) 1 (<1) 4 (2) 4 (1)
 Oropharyngeal candidiasis 1 (<1) 1 (<1) 7 (<1) 9 (1) 1 (<1) 2 (<1) 6 (2)
LRTI excluding pneumonia 16 (2) 1 (<1) 114 (7) 19 (3) 3 (1) 5 (2) 7 (2)
 Bronchitis 15 (2) 0 98 (6) 15 (2) 3 (1) 5 (2) 7 (2)
 Hypersensitivityb 13 (2) 3 (<1) 41 (2) 6 (<1) 2 (<1) 2 (<1) 6 (2)
 Bone disordersb 0 2 (<1) 21 (1) 2 (<1) 1 (<1) 0 4 (1)
 Pneumoniab 2 (<1) 0 10 (<1) 4 (<1) 1 (<1) 0 0
 Effects on glucoseb 0 0 11 (<1) 2 (<1) 0 0 0
 Ocular effectsb 0 0 6 (<1) 0 0 0 0
   Exposure-adjusted incidence rate per 1000 patient-years
AE of special interest (preferred term), n (%) Placebo FF 50 μg OD FF 100 μg OD FF 200 μg OD FP 100 μg BD FP 250 μg BD FP 500 μg BD
Patient-years 185.6 87.5 1179.4 169.2 61.0 60.3 95.7
 Local steroid effects 80.8 80.0 103.4 283.8 131.1 298.6 261.2
 Oropharyngeal pain 59.3 22.9 60.2 112.3 65.6 99.5 114.9
 Dysphonia 21.6 11.4 19.5 65.0 49.2 99.5 62.7
 Oral candidiasis 0 45.7 15.3 47.3 16.4 66.4 41.8
 Oropharyngeal candidiasis 5.4 11.4 5.9 53.2 16.4 33.2 62.7
LRTI excluding pneumonia 86.2 11.4 96.7 112.3 49.2 82.9 73.1
 Bronchitis 80.8 0 83.1 88.7 49.2 82.9 73.1
 Hypersensitivityb 70.0 34.3 34.8 35.5 32.8 33.2 62.7
 Bone disordersb 0 22.9 17.8 11.8 16.4 0 41.8
 Pneumoniab 10.8 0 8.5 23.6 16.4 0 0
 Effects on glucoseb 0 0 9.3 11.8 0 0 0
 Ocular effectsb 0 0 5.1 0 0 0 0
  1. AE adverse event, BD twice daily, FF fluticasone furoate, FP fluticasone propionate, LRTI lower respiratory tract infection, OD once daily
  2. aNumbers represent the number of patients with an event per 1000 patient-years of exposure
  3. bNo individual event occurred in ≥1% of patients