| |
Treatment-emergent AEs
|
Treatment-related AEs
|
|---|
|
AEs, no. (% of subjects experiencing)
|
Placebo (n = 166)
|
Grass AIT (n = 163)
|
Placebo (n = 166)
|
Grass AIT (n = 163)
|
|---|
|
Ear pruritus
|
1 (<1)
|
16 (10)
|
1 (<1)
|
16 (10)
|
|
Mouth edema
|
0 (0)
|
9 (6)
|
0 (0)
|
9 (6)
|
|
Oral pruritus
|
1 (<1)
|
29 (18)
|
1 (<1)
|
28 (17)
|
|
Nasopharyngitis
|
24 (14)
|
23 (14)
|
0 (0)
|
1 (<1)
|
|
Sinusitis
|
6 (4)
|
12 (7)
|
1 (<1)
|
0 (0)
|
|
URTI
|
15 (9)
|
17 (10)
|
0 (0)
|
0 (0)
|
|
Headache
|
12 (7)
|
8 (5)
|
1 (<1)
|
1 (<1)
|
|
Paraesthesia oral
|
2 (1)
|
14 (9)
|
2 (1)
|
14 (9)
|
|
Throat irritation
|
4 (2)
|
24 (15)
|
4 (2)
|
23 (14)
|
|
Urticaria
|
0 (0)
|
8 (5)
|
0 (0)
|
6 (4)
|
- AE Adverse event, AIT Allergy immunotherapy tablet, URTI Upper respiratory tract infection.
