Table 3.
Most commonly reported adverse events by system organ class
| Cohort 1 | Cohort 2 | ||
|---|---|---|---|
| Common cold (n = 18) | No cold symptoms (n = 17) | Common cold + Decongestant (n = 18) | |
| Total AEs reported, n | 112 | 64 | 113 |
| Patients with ≥1 AE, n (%) | 18 (100) | 17 (100) | 18 (100) |
| Patients with ≥1 treatment‐related AE, n (%) | 18 (100) | 17 (100) | 18 (100) |
| Serious AEs reported, n | 0 | 0 | 0 |
|
AEs by system organ class
Preferred term, n (%) |
n (%) | n (%) | n (%) |
| Ocular | |||
| Increased lacrimation | 13 (72.2) | 12 (70.6) | 12 (66.7) |
| Ocular hyperaemia | 7 (38.9) | 7 (41.2) | 8 (44.4) |
| Eye pruritus | 5 (27.8) | 0 | 5 (27.8) |
| Respiratory | |||
| Nasal discomfort | 12 (66.7) | 7 (41.2) | 15 (83.3) |
| Rhinorrhea | 10 (55.6) | 5 (29.4) | 14 (77.8) |
| Nasal congestion | 4 (22.2) | 3 (17.6) | 4 (22.2) |
| Sneezing | 5 (27.8) | 3 (17.6) | 3 (16.7) |
| Nervous system | |||
| Dizziness | 4 (22.2) | 5 (29.4) | 5 (27.8) |
| Headache | 4 (22.2) | 3 (17.6) | 5 (27.8) |
| Somnolence | 6 (33.3) | 3 (17.6) | 1 (5.6) |
| Gastrointestinal | |||
| Nausea | 8 (44.4) | 2 (11.8) | 7 (38.9) |
| Vomiting | 1 (5.6) | 0 | 5 (27.8) |
Abbreviation: AE, adverse event.