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

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)

 Hypersensitivity^b

13 (2)

3 (<1)

41 (2)

6 (<1)

2 (<1)

2 (<1)

6 (2)

 Bone disorders^b

0

2 (<1)

21 (1)

2 (<1)

1 (<1)

0

4 (1)

 Pneumonia^b

2 (<1)

0

10 (<1)

4 (<1)

1 (<1)

0

0

 Effects on glucose^b

0

0

11 (<1)

2 (<1)

0

0

0

 Ocular effects^b

0

0

6 (<1)

0

0

0

0

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

 Hypersensitivity^b

70.0

34.3

34.8

35.5

32.8

33.2

62.7

 Bone disorders^b

0

22.9

17.8

11.8

16.4

0

41.8

 Pneumonia^b

10.8

0

8.5

23.6

16.4

0

0

 Effects on glucose^b

0

0

9.3

11.8

0

0

0

 Ocular effects^b

0

0

5.1

0

0

0

0