TABLE 4.
Treatment-emergent adverse events that occurred in ≥2 subjects in any treatment group (safety analysis set)a
| TEAEb | No. of subjects (%) for treatment group: |
||
|---|---|---|---|
| RV521 350 mg (N = 22) | RV521 200 mg (N = 22) | Placebo (N = 22) | |
| Abdominal pain | 5 (23) | 2 (9) | 0 |
| Diarrhea | 9 (41) | 3 (14) | 1 (5) |
| Nausea | 12 (55) | 2 (9) | 2 (9) |
| Vomiting | 2 (9) | 1 (5) | 0 |
| Rhinitis | 2 (9) | 1 (5) | 1 (5) |
| URTI | 0 | 2 (9) | 0 |
| Viral URTI | 2 (9) | 0 | 0 |
| Headache | 0 | 0 | 2 (9) |
| Rash | 0 | 0 | 2 (9) |
a
Respiratory tract infection symptoms were only captured as an AE if they were unexpected as a result of the virus challenge, met the criteria for an AE, and were deemed clinically significant in the opinion of the investigator.
b
AE, adverse event; TEAE, treatment-emergent adverse event; URTI, upper respiratory tract infection.