Sublingual Immunotherapy with a Five-Grass Pollen Tablet in Adult Patients with Allergic Rhinitis: An Open, Prospective, Noninterventional, Multicenter Study
Table 3
Adverse events (in general and those related to treatment, i.e., adverse drug reactions) having occurred in at least 1% of the 808 patients during the first year of SLIT.
MedDRA system organ class and preferred term (PT)
Number of patients (%)
Number of events
AEs (total)
297 (36.8)
758
Treatment-related AEs (=ADRs) (total)
285 (35.3)
720
Ear and labyrinth disorders
17 (2.1)
18
Ear pruritus
15 (1.9)
16
Eye disorders
14 (1.7)
19
Eye pruritus
8 (1.0)
9
Gastrointestinal disorders
222 (27.5)
411
Paresthesia oral
88 (10.9)
118
Oral pruritus
56 (6.9)
74
Edema mouth
43 (5.3)
52
Oral discomfort
20 (2.5)
24
Nausea
16 (2.0)
18
Lip swelling
12 (1.5)
13
Glossodynia
11 (1.4)
15
Tongue edema
11 (1.4)
11
Hypoesthesia oral
10 (1.2)
10
Dyspepsia
9 (1.1)
11
Dysphagia
9 (1.1)
11
Nervous system disorders
26 (3.2)
31
Paresthesia
9 (1.1)
12
Respiratory, thoracic, and mediastinal disorders
110 (13.6)
163
Throat irritation
62 (7.7)
80
Pharyngeal edema
14 (1.7)
16
Dyspnea
10 (1.2)
12
Sneezing
9 (1.1)
9
Cough
8 (1.0)
8
Skin and subcutaneous tissue disorders
25 (3.1)
35
Pruritus
15 (1.9)
17
MedDRA: Medical Dictionary for Regulatory Activities, Version 11.1. %: percentage of patients; AE: adverse event; ADR: adverse drug reaction.
