Table 4.
Overview most frequent related AEs (safety population)
|
Symptom/sign
a
|
|
SUB-B |
Stal-B |
||||
|---|---|---|---|---|---|---|---|
| Grade | No. of symptoms | No. of subjects | % of subjects | No. of symptoms | No. of subjects | % of subjects | |
|
Local reactions |
|
|
|
|
|
|
|
| Pruritus/swelling of mouth, tongue or lip |
I |
44 |
24 |
63.2 |
31 |
22 |
61.1 |
| II |
1 |
1 |
2.6 |
0 |
0 |
0 |
|
| Throat irritation |
I |
4 |
3 |
7.9 |
5 |
2 |
5.6 |
| Ear pruritus |
I |
4 |
4 |
10.5 |
3 |
1 |
2.8 |
| Nausea |
I |
3 |
2 |
5.3 |
0 |
0 |
0 |
| Abdominal pain |
I |
3 |
3 |
7.9 |
1 |
1 |
2.8 |
|
Systemic reactions |
|
|
|
|
|
|
|
|
Upper respiratory |
|
|
|
|
|
|
|
| Rhinitis (e.g., sneezing, rhinorrhea, nasal pruritus, and/or nasal congestion) |
I |
10 |
5 |
13.2 |
8 |
6 |
16.7 |
| Cough |
I |
2 |
2 |
5.3 |
1 |
1 |
2.8 |
|
Conjunctival |
|
|
|
|
|
|
|
| Conjunctival erythema, pruritus , or tearing |
I |
2 |
2 |
5.3 |
3 |
2 |
5.6 |
|
Other |
|
|
|
|
|
|
|
| Headache | I | 1 | 1 | 2.6 | 3 | 2 | 5.6 |