Table 5 Adverse events experienced by 5% or more of all treated subjects
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) |