Table 4.
Adverse events by preferred term- multiple-dose study (Part 2).
Anti-SARS-CoV-2 IgY | |||||
---|---|---|---|---|---|
2 mg TID | 4 mg TID | 8 mg TID | Placebo TID | All Participants | |
(N=6) | (N=6) | (N=6) | (N=6) | (N=24) | |
n (%) E | n (%) E | n (%) E | n (%) E | n (%) E | |
Participants with ≥1 TEAE | 4 (66.7%) 7 | 2 (33.3%) 3 | 4 (66.7%) 5 | 4 (66.7%) 5 | 14 (58.3%) 20 |
MedDRA Preferred Term | |||||
Headache | 0 | 0 | 3 (50.0%) 3 | 2 (33.3%) 2 | 5 (20.8%) 5 |
Upper respiratory tract infection | 0 | 0 | 1 (16.7%) 1 | 1 (16.7%) 1 | 2 (8.3%) 2 |
Contusion | 0 | 0 | 0 | 1 (16.7%) 1 | 1 (4.2%) 1 |
Dental discomfort | 1 (16.7%) 1 | 0 | 0 | 0 | 1 (4.2%) 1 |
Dizziness | 1 (16.7%) 1 | 0 | 0 | 0 | 1 (4.2%) 1 |
Ear pain | 1 (16.7%) 1 | 0 | 0 | 0 | 1 (4.2%) 1 |
Epistaxis | 1 (16.7%) 1 | 0 | 0 | 0 | 1 (4.2%) 1 |
Eyelid irritation | 0 | 0 | 1 (16.7%) 1 | 0 | 1 (4.2%) 1 |
Injection site hematoma | 1 (16.7%) 1 | 0 | 0 | 0 | 1 (4.2%) 1 |
Nasal congestion | 0 | 0 | 0 | 1 (16.7%) 1 | 1 (4.2%) 1 |
Parosmia | 0 | 1 (16.7%) 1 | 0 | 0 | 1 (4.2%) 1 |
Presyncope | 1 (16.7%) 1 | 0 | 0 | 0 | 1 (4.2%) 1 |
Rhinorrhea | 0 | 1 (16.7%) 1 | 0 | 0 | 1 (4.2%) 1 |
Skin abrasion | 0 | 1 (16.7%) 1 | 0 | 0 | 1 (4.2%) 1 |
Tenderness | 1 (16.7%) 1 | 0 | 0 | 0 | 1 (4.2%) 1 |
E, number of events; n, number of participants; TEAE, treatment-emergent adverse event.