Table 3.
Safety summary – Number and percent of participants experiencing AEs
| Study arm and period | Number of participants* | Any adverse event | Organ system | Treated | Grade AE1 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal2 | General3 | Respiratory | Skin | Other4 | 1 | 2 | 3 | ||||
| Year 1 | |||||||||||
| Peanut-0 | 60 | 57 (95%) | 52 (87%) |
11 (18%) |
27 (45%) | 34 (57%) |
5 (8%) |
50 (83%) | 53 (88%) | 42 (70%) | 1 (2%) |
| Peanut-300 | 35 | 32 (91%) | 29 (83%) |
9 (26%) |
18 (51%) | 17 (49%) |
2 (6%) |
28 (80%) | 30 (86%) | 23 (66%) | 0 |
| Placebo | 25 | 16 (64%) | 12 (48%) |
1 (4%) |
6 (24%) |
10 (40%) |
1 (4%) |
11 (44%) | 13 (52%) | 11 (44%) | 1 (4%) |
| Year 2 | |||||||||||
| Peanut-0 | 55 | 40 (73%) | 35 (64%) |
15 (27%) |
21 (38%) | 25 (45%) |
2 (4%) |
35 (64%) | 34 (62%) | 29 (53%) | 3 (5%) |
| Peanut-300 | 31 | 20 (65%) | 15 (48%) |
5 (16%) |
9 (29%) |
11 (35%) |
2 (6%) |
18 (58%) | 16 (52%) | 13 (42%) | 1 (3%) |
| Placebo | 23 | 6 (26%) |
5 (22%) |
1 (3%) |
3 (13%) |
2 (9%) |
0 | 3 (13%) |
6 (26%) | 2 (9%) |
0 |
| Year 3 | |||||||||||
| Peanut-0 | 51 | 1 (2%) |
1 (2%) |
0 | 0 | 0 | 0 | 0 | 1 (2%) |
0 | 0 |
| Peanut-300 | 30 | 6 (20%) |
4 (13%) |
0 | 3 (10%) |
2 (7%) |
0 | 6 (20%) |
4 (13%) | 6 (20%) | 0 |
| Placebo | 20 | 1 (5%) |
1 (5%) |
0 | 1 (5%) |
0 | 0 | 0 | 1 (5%) |
0 | 0 |
*
Number of subjects with at least 1 AE during the year out of the number of subjects with doses during that year. Peanut-0 = oral immunotherapy with discontinuation arm; Peanut-300 = oral immunotherapy with peanut continuation arm (300 mg).
1
CTCAE v.4·03 grade where 1, 2, 3 is grade 1, 2, and 3, respectively.
2
Gastrointestinal includes itchy oropharynx.
3
General indicates skin reactions at injection site.
4
Other indicates anxiety or eye reactions.