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Table 3 Most frequent on-treatment AEs reported with ≥ 3% incidence in any treatment groups (integrated clinical studies)

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

AE (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)
Any AE 278 (32) 121 (36) 912 (55) 256 (42) 94 (43) 90 (42) 136 (45)
Headache 66 (8) 29 (9) 228 (14) 44 (7) 24 (11) 15 (7) 25 (8)
Nasopharyngitis 45 (5) 15 (4) 181 (11) 53 (9) 14 (6) 11 (5) 43 (14)
URTI 16 (2) 8 (2) 111 (7) 15 (2) 7 (3) 12 (6) 7 (2)
Bronchitis 15 (2) 0 98 (6) 15 (2) 3 (1) 5 (2) 7 (2)
Oropharyngeal pain 11 (1) 2 (<1) 71 (4) 19 (3) 4 (2) 6 (3) 11 (4)
Cough 9 (1) 3 (<1) 68 (4) 13 (2) 2 (<1) 5 (2) 15 (5)
Pharyngitis 24 (3) 14 (4) 55 (3) 8 (1) 5 (2) 2 (<1) 7 (2)
Sinusitis 8 (<1) 5 (1) 53 (3) 15 (2) 6 (3) 5 (2) 6 (2)
Influenza 9 (1) 5 (1) 45 (3) 17 (3) 6 (3) 0 7 (2)
Back pain 4 (<1) 7 (2) 52 (3) 11 (2) 4 (2) 2 (<1) 4 (1)
Dysphonia 4 (<1) 1 (<1) 23 (1) 11 (2) 3 (1) 6 (3) 6 (2)
Rhinitis 7 (<1) 1 (<1) 27 (2) 7 (1) 3 (1) 0 8 (3)
Viral respiratory tract infection 0 2 (<1) 18 (1) 8 (1) 0 0 8 (3)
  Exposure-adjusted incidence rate per 1000 patient-years
AE
(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
Headache 355.6 331.5 193.3 260.1 393.4 248.8 261.2
Nasopharyngitis 242.5 171.5 153.5 313.3 229.5 182.5 449.3
URTI 86.2 91.4 94.1 88.7 114.8 199.1 73.1
Bronchitis 80.8 0 83.1 88.7 49.2 82.9 73.1
Oropharyngeal pain 59.3 22.9 60.2 112.3 65.6 99.5 114.9
Cough 48.5 34.3 57.7 76.9 32.8 82.9 156.7
Pharyngitis 129.3 160.0 46.6 47.3 82.0 33.2 73.1
Sinusitis 43.1 57.2 44.9 88.7 98.4 82.9 62.7
Influenza 48.5 57.2 38.2 100.5 98.4 0 73.1
Back pain 21.6 80.0 44.1 65.0 65.6 33.2 41.8
Dysphonia 21.6 11.4 19.5 65.0 49.2 99.5 62.7
Rhinitis 37.7 11.4 22.9 41.4 49.2 0 83.6
Viral respiratory tract infection 0 22.9 15.3 47.3 0 0 83.6
  1. AE adverse event, BD twice daily, FF fluticasone furoate, FP fluticasone propionate, OD once daily, URTI upper respiratory tract infection
  2. aNumbers represent the number of patients with an event per 1000 patient-years of exposure