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Table 2 Incidence of TEAEs reported by at least 5% of participants in either treatment group

From: Sustained efficacy and safety of a 300IR daily dose of a sublingual solution of birch pollen allergen extract in adults with allergic rhinoconjunctivitis: results of a double-blind, placebo-controlled study

System organ class Preferred term

Overall population

With OAS

Without OAS

300IR

Placebo

300IR

Placebo

300IR

Placebo

(N = 283)

(N = 289)

(N = 152)

(N = 158)

(N = 131)

(N = 131)

n (%)

n (%)

n (%)

n (%)

n (%)

n (%)

PERIOD 1

Patients who had at least one TEAE

200 (70.7)

185 (64.0)

119 (78.3)

116 (73.4)

81 (61.8)

69 (52.7)

Gastrointestinal disorders

126 (44.5)

54 (18.7)

83 (54.6)

36 (22.8)

43 (32.8)

18 (13.7)

Oral pruritus

70 (24.7)

11 (3.8)

47 (30.9)

7 (4.4)

23 (17.6)

4 (3.1)

Edema mouth

28 (9.9)

0 (0.0)

21 (13.8)

0 (0.0)

7 (5.3)

0 (0.0)

Infections and infestations

89 (31.4)

106 (36.7)

57 (37.5)

71 (44.9)

32 (24.4)

35 (26.7)

Nasopharyngitis

31 (11.0)

43 (14.9)

23 (15.1)

26 (16.5)

8 (6.1)

17 (13.0)

Respiratory, thoracic, mediastinal disorders

64 (22.6)

43 (14.9)

42 (27.6)

30 (19.0)

22 (16.8)

13 (9.9)

Throat irritation

19 (6.7)

2 (0.7)

14 (9.2)

2 (1.3)

5 (3.8)

0 (0.0)

Nervous system disorders

53 (18.7)

53 (18.3)

38 (25.0)

37 (23.4)

15 (11.5)

16 (12.2)

Headache

49 (17.3)

44 (15.2)

34 (22.4)

31 (19.6)

15 (11.5)

13 (9.9)

Musculoskeletal and connective tissue disorders

25 (8.8)

27 (9.3)

17 (11.2)

15 (9.5)

8 (6.1)

12 (9.2)

Eye disorders

22 (7.8)

27 (9.3)

17 (11.2)

17 (10.8)

5 (3.8)

10 (7.6)

Skin and subcutaneous tissue disorders

13 (4.6)

17 (5.9)

7 (4.6)

15 (9.5)

6 (4.6)

2 (1.5)

PERIOD 2

 

300IR

Placebo

300IR

Placebo

300IR

Placebo

(N = 252)

(N = 259)

(N = 134)

(N = 142)

(N = 118)

(N = 117)

n (%)

n (%)

n (%)

n (%)

n (%)

n (%)

Patients who had TEAE

118 (46.8)

126 (48.6)

68 (50.7)

80 (56.3)

50 (42.2)

46 (39.3)

Infections and infestations

65 (25.8)

77 (29.7)

41 (30.6)

50 (35.2)

24 (20.3)

27 (23.1)

Nasopharyngitis

19 (7.5)

34 (13.1)

12 (9.0)

22 (15.5)

7 (5.9)

12 (10.3)

Gastrointestinal disorders

41 (16.3)

23 (8.9)

27 (20.1)

15 (10.6)

14 (11.9)

8 (6.8)

Oral pruritus

21 (8.3)

2 (0.8)

14 (10.4)

2 (1.4)

7 (5.9)

0 (0)

Nervous system disorders

17 (6.7)

21 (8.1)

11 (8.2)

19 (13.4)

6 (5.1)

2 (1.7)

Headache

13 (5.2)

17 (6.6)

10 (7.5)

16 (11.3)

3 (2.5)

1 (0.9)

Respiratory, thoracic, mediastinal disorders

14 (5.6)

21 (8.1)

10 (7.5)

14 (9.9)

4 (3.4)

7 (6.0)

Musculoskeletal and connective tissue disorders

14 (5.6)

18 (6.9)

7 (5.2)

12 (8.5)

7 (5.9)

6 (5.1)

  1. Safety SetP1, Safety SetP2. Adverse events were classified according to their system organ class and preferred term (MedDRA version 14.0).
  2. TEAEs were adverse events occurring during the treatment period up to 30 days after the last treatment administration.
  3. n = number of patients with at least one event in given preferred term; % = percentage of patients with at least one event relative to the number of patients in each treatment group (N) in the Safety Sets.
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Clinical and Translational Allergy

ISSN: 2045-7022

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