Table 5 ADRs related to the concomitant AIT in ≥1 % of patients (in at least one treatment group)
MedDRA system organ class MedDRA preferred term | Concomitant SCIT n (%), E | Concomitant SLIT n (%), E | Concomitant AIT n (%), E |
|---|---|---|---|
Patients | 130 | 30 | 160 |
All patients with ADRs | 17 (13.1), 96 | 1 (3.3), 3 | 18 (11.3), 99 |
Ear and labyrinth disorders | 3 (2.3), 5 | – | 3 (1.9), 5 |
Ear pruritus | 2 (1.5), 3 | – | 2 (1.3), 3 |
Gastrointestinal disorders | 4 (3.1), 10 | 1 (3.3), 1 | 5 (3.1), 11 |
Abdominal pain | – | 1 (3.3), 1 | 1 (0.6), 1 |
General disorders and administration site conditions | 13 (10.0), 39 | – | 13 (8.1), 39 |
Fatigue | 3 (2.3), 12 | – | 3 (1.9), 12 |
Injection site pruritus | 4 (3.1), 7 | – | 4 (2.5), 7 |
Injection site swelling | 5 (3.8), 5 | – | 5 (3.1), 5 |
Respiratory, thoracic and mediastinal disorders | 6 (4.6), 20 | 1 (3.3), 1 | 7 (4.4), 21 |
Oropharyngeal pain | – | 1 (3.3), 1 | 1 (0.6), 1 |
Sneezing | 3 (2.3), 4 | – | 3 (1.9), 4 |
Skin and subcutaneous tissue disorders | 4 (3.1), 9 | 1 (3.3), 1 | 5 (3.1), 10 |
Pruritus | 2 (1.5), 7 | – | 2 (1.3), 7 |
Rash | 1 (0.8), 1 | 1 (3.3), 1 | 2 (1.3), 2 |