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Table 4 ADRs related to the SQ® grass SLIT-tablet in ≥1 % of patients

From: Tolerability of the SQ-standardised grass sublingual immunotherapy tablet in patients treated with concomitant allergy immunotherapy: a non-interventional observational study

MedDRA system organ class

MedDRA preferred term

Concomitant AIT

n (%), E

No concomitant AIT

n (%), E

All patients treated

n (%), E

Patients

160

21

181

All patients with ADRs

49 (30.6), 358

8 (38.1), 37

57 (31.5), 395

Ear and labyrinth disorders

8 (5.0), 18

8 (4.4), 18

 Ear pruritus

7 (4.4), 17

7 (3.9), 17

Eye disorders

6 (3.8), 11

6 (3.3), 11

 Eye pruritus

3 (1.9), 4

3 (1.7), 4

 Eye irritation

2 (1.3), 6

2 (1.1), 6

Gastrointestinal disorders

35 (21.9), 131

5 (23.8), 29

40 (22.1), 160

 Oral pruritus

14 (8.8), 34

1 (4.8), 6

15 (8.3), 40

 Oedema mouth

10 (6.3), 16

3 (14.3), 3

13 (7.2), 19

 Paraesthesia oral

8 (5.0), 21

3 (14.3), 10

11 (6.1), 31

 Dysphagia

6 (3.8), 11

6 (3.3), 11

 Hypoaesthesia oral

4 (2.5), 5

1 (4.8), 2

5 (2.8), 7

 Oral discomfort

4 (2.5), 6

4 (2.2), 6

 Lip swelling

2 (1.3), 2

2 (9.5), 6

4 (2.2), 8

 Tongue pruritus

3 (1.9), 4

3 (1.7), 4

 Nausea

3 (1.9), 4

3 (1.7), 4

 Swollen tongue

2 (1.3), 2

2 (1.1), 2

 Lip pruritus

2 (1.3), 2

2 (1.1), 2

 Glossodynia

2 (1.3), 4

2 (1.1), 4

 Abdominal pain upper

2 (1.3), 2

2 (1.1), 2

General disorders and administration site conditions

11 (6.9), 38

11 (6.1), 38

 Fatigue

3 (1.9), 13

_

3 (1.7), 13

 Sensation of foreign body

3 (1.9), 8

3 (1.7), 8

 Injection site pruritus

2 (1.3), 2

2 (1.1), 2

Infections and infestations

2 (1.3), 6

2 (1.1), 6

 Nasopharyngitis

2 (1.3), 6

2 (1.1), 6

Nervous system disorders

6 (3.8), 26

2 (9.5), 3

8 (4.4), 29

 Headache

3 (1.9), 19

2 (9.5), 3

5 (2.8), 22

 Dizziness

2 (1.3), 3

2 (1.1), 3

Respiratory, thoracic and mediastinal disorders

30 (18.8), 94

3 (14.3), 4

33 (18.2), 98

 Throat irritation

13 (8.1), 34

13 (7.2), 34

 Sneezing

7 (4.4), 11

7 (3.9), 11

 Cough

5 (3.1), 8

5 (2.8), 8

 Oropharyngeal pain

3 (1.9), 8

3 (1.7), 8

 Pharyngeal oedema

2 (1.3), 3

1 (4.8), 2

3 (1.7), 5

 Nasal discomfort

2 (1.3), 2

1 (4.8), 1

3 (1.7), 3

 Rhinorrhea

3 (1.9), 4

3 (1.7), 4

 Dyspnoea

2 (1.3), 5

2 (1.1), 5

 Nasal congestion

2 (1.3), 5

2 (1.1), 5

 Rhinitis allergic

2 (1.3), 2

2 (1.1), 2

 Dry throat

2 (1.3), 2

2 (1.1), 2

Skin and subcutaneous disorders

9 (5.6), 23

1 (4.8), 1

10 (5.5), 24

 Pruritus

6 (3.8), 17

6 (3.3), 17

 Rash

3 (1.9), 3

3 (1.7), 3