Table 3 Adverse events reported in the Canadian populations of the pooled adult-pediatric 2009 trials and the adult-pediatric 2012 trial
Pooled adult-pediatric 2009 trials | Adult-pediatric 2012 trial | |||
|---|---|---|---|---|
Grass SLIT-T(n=47) | PBO(n=56) | Grass SLIT-T(n=142) | PBO(n=140) | |
Any TEAE, n (%) | 31 (66.0) | 25 (44.6) | 93 (65.5) | 69 (49.3) |
TRAE, n (%) | 21 (44.7) | 8 (14.3) | 70 (49.3) | 32 (22.9) |
Discontinued due to TRAE, n (%) | 1 (2.1) | 0 | 7 (4.9) | 4 (2.9) |
Local application- site TRAE, n (%) | ||||
Oral pruritus | 7 (14.9) | 2 (3.6) | 30 (21.1) | 6 (4.3) |
Ear pruritus | 9 (19.1) | 2 (3.6) | 20 (14.1) | 5 (3.6) |
Edema mouth | 0 | 0 | 24 (16.9) | 6 (4.3) |
Eye pruritus | 0 | 1 (1.8) | 4 (2.8) | 6 (4.3) |
Throat irritation | 14 (29.8) | 1 (1.8) | 47 (33.1) | 10 (7.1) |
Nasal passage irritation | 1 (2.1) | 2 (3.6) | 6 (4.2) | 9 (6.4) |
Skin pruritus | 2 (4.3) | 2 (3.6) | 6 (4.2) | 2 (1.4) |