TABLE 3.
TEAEs, N = 163
| Variable | n (%) |
|---|---|
| Patients with TEAEs | 134 (82.2) |
| Patients with serious TEAEs | 50 (30.7) |
| Death | 1 (.6) |
| Important medical events | 10 (6.1) |
| Required/prolonged hospitalization | 44 (27.0) |
| Most common TEAEs, occurring in >5% of patients | |
| Seizure | 31 (19.0) |
| Nasopharyngitis | 20 (12.3) |
| Upper respiratory tract infection | 20 (12.3) |
| Pyrexia | 17 (10.4) |
| Influenza | 13 (8.0) |
| Pneumonia | 12 (7.4) |
| Somnolence | 11 (6.7) |
| Urinary tract infection | 11 (6.7) |
| Nasal discomfort | 10 (6.1) |
| Diarrhea | 9 (5.5) |
| Vomiting | 9 (5.5) |
| Patients with related a TEAEs, occurring in >2 patients | 30 (18.4) |
| Nasal discomfort | 10 (6.1) |
| Headache | 4 (2.5) |
| Dysgeusia | 3 (1.8) |
| Epistaxis | 3 (1.8) |
| Somnolence | 3 (1.8) |
| Cough | 2 (1.2) |
| Eye irritation | 2 (1.2) |
| Fatigue | 2 (1.2) |
| Lacrimation increased | 2 (1.2) |
| Migraine | 2 (1.2) |
| Rhinalgia | 2 (1.2) |
| Rhinorrhea | 2 (1.2) |
Abbreviation: TEAE, treatment‐emergent adverse event.
a
Classified as possibly or probably related to treatment.