Table 3: Summary of treatment-emergent adverse events.
| Group A (n=36) | Group B (n=15) | Total (n=51) | ||||
|---|---|---|---|---|---|---|
| Number of patients (%) | Number of events | Number of patients (%) | Number of events | Number of patients (%) | Number of events | |
| Events | 25 (69.4) | 70 | 11 (73.3) | 25 | 36 (70.6) | 95 |
| Serious | ||||||
| Yes | 4 (11.1) | 4 | 2 (13.3) | 2 | 6 (11.8) | 6 |
| No | 24 (66.7) | 66 | 10 (66.7) | 23 | 34 (66.7) | 89 |
| Severity | ||||||
| Mild | 22 (61.1) | 59 | 8 (53.3) | 18 | 30 (58.8) | 77 |
| Moderate | 6 (16.7) | 11 | 4 (26.7) | 7 | 10 (19.6) | 18 |
| Adverse events occurring in ≥5% of patients in either group | ||||||
| Events | 20 (55.6) | 56 | 11 (73.3) | 24 | 31 (60.8) | 81 |
| Eye disorders | 0 (0.0) | 0 | 1 (6.7) | 1 | 1 (2.0) | 1 |
| General disorders and administration site conditions | ||||||
| Chest pain | 0 (0.0) | 0 | 1 (6.7) | 1 | 1 (2.0) | 1 |
| Pyrexia | 2 (5.6) | 2 | 0 (0.0) | 0 | 2 (3.9) | 2 |
| Infections and infestations | ||||||
| Conjunctivitis | 0 (0.0) | 0 | 1 (6.7) | 1 | 1 (2.0) | 1 |
| Influenza | 3 (8.3) | 3 | 0 (0.0) | 0 | 3 (5.9) | 3 |
| Nasopharyngitis | 15 (41.7) | 43 | 7 (46.7) | 14 | 22 (43.1) | 57 |
| Pharyngotonsillitis | 2 (5.6) | 2 | 0 (0.0) | 0 | 2 (3.9) | 2 |
| Pneumonia | 0 (0.0) | 0 | 1 (6.7) | 1 | 1 (2.0) | 1 |
| Rhinitis | 0 (0.0) | 0 | 2 (13.3) | 3 | 2 (3.9) | 3 |
| Upper respiratory tract infection | 3 (8.3) | 3 | 1 (6.7) | 1 | 4 (7.8) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Rhinitis allergic | 0 (0.0) | 0 | 1 (6.7) | 1 | 1 (2.0) | 1 |
| Tonsillar hypertrophy | 0 (0.0) | 0 | 1 (6.7) | 1 | 1 (2.0) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis | 0 (0.0) | 0 | 1 (6.7) | 1 | 1 (2.0) | 1 |
| Urticaria | 3 (8.3) | 3 | 0 (0.0) | 0 | 3 (5.9) | 3 |
Data based on the safety analysis set.