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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.