TABLE 2.
Treatment‐emergent adverse events (TEAEs) in the second‐dose subgroup and overall population
| Category, n (%) |
Second‐dose subgroup (n = 79) |
Overall population (N = 163) |
|---|---|---|
| Number of patients with TEAEs | 67 (84.8) | 134 (82.2) |
| Number of patients with SAEs | 28 (35.4) | 50 (30.7) |
| Death | 1 (1.3) a | 1 (0.6) a |
| Important medical events | 6 (7.6) | 10 (6.1) |
| Requires/prolongs hospitalization | 25 (31.6) | 44 (27.0) |
| Number of patients who discontinued due to a TEAE | 1 (1.3) a | 1 (0.6) a |
| Number of patients with treatment‐related TEAEs | 19 (24.1) | 30 (18.4) |
| Most common TEAEs (>5% in the second dose group) | ||
| Seizure | 16 (20.3) | 31 (19.0) |
| Nasopharyngitis | 15 (19.0) | 20 (12.3) |
| Upper respiratory tract infection | 10 (12.7) | 20 (12.3) |
| Influenza | 9 (11.4) | 13 (8.0) |
| Pyrexia | 8 (10.1) | 17 (10.4) |
| Somnolence | 8 (10.1) | 11 (6.7) |
| Vomiting | 7 (8.9) | 9 (5.5) |
| Diarrhea | 6 (7.6) | 9 (5.5) |
| Headache | 6 (7.6) | 7 (4.3) |
| Nausea | 6 (7.6) | 8 (4.9) |
| Constipation | 5 (6.3) | 8 (4.9) |
| Epilepsy | 5 (6.3) | 6 (3.7) |
| Nasal discomfort | 5 (6.3) | 10 (6.1) |
| Status epilepticus | 5 (6.3) | 7 (4.3) |
| Urinary tract infection | 5 (6.3) | 11 (6.7) |
| Cough | 4 (5.1) | 8 (4.9) |
| Ear infection | 4 (5.1) | 7 (4.3) |
| Pneumonia | 4 (5.1) | 12 (7.4) |
Abbreviation: SAE, serious adverse event.
a
Not deemed possibly or probably treatment related.