TABLE 4.
Treatment‐emergent adverse events ≥5% and ≥2 patients in any frequency of use group
| TEAE, n (%) |
Moderate‐frequency usage (<2 doses/month) (n = 69) |
High‐frequency usage (2‐5 doses/month) (n = 80) |
Very‐high‐frequency usage (>5 doses/month) (n = 9)a |
|---|---|---|---|
| Nasopharyngitis | 1 (1.4) | 10 (12.5) | 1 (11.1) |
| Seizure | 13 (18.8) | 9 (11.3) | 1 (11.1) |
| Influenza | 1 (1.4) | 6 (7.5) | 1 (11.1) |
| Pyrexia | 4 (5.8) | 6 (7.5) | — |
| Somnolence | 2 (2.9) | 5 (6.3) | — |
| Status epilepticus | — | 5 (6.3) | — |
| Upper respiratory tract infection | 8 (11.6) | 4 (5.0) | — |
| Pneumonia | 6 (8.7) | 4 (5.0) | 1 (11.1) |
| Urinary tract infection | 3 (4.3) | 4 (5.0) | — |
| Nasal discomfort | 3 (4.3) | 4 (5.0) | 2 (22.2) |
| Vomiting | 3 (4.3) | 4 (5.0) | — |
| Contusion | — | 4 (5.0) | — |
| Headache | 2 (2.9) | 3 (3.8) | 2 (22.2) |
| Dizziness | 5 (7.2) | 2 (2.5) | — |
| Sinusitis | 4 (5.8) | 2 (2.5) | — |
Abbreviation: TEAE, treatment‐emergent adverse event.
a
In the >5 doses/month group, headache and nasal discomfort occurred in two patients, with no other TEAEs occurring in more than one patient.