Skip to main content

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
Back to article page

Respiratory Research

ISSN: 1465-993X

Contact us