Table 3.
TEAEs occurring in two or more participants during the OLE (safety population)
| TEAE, n (%) | Re-entry (n = 27) | Rollover (n = 47) | Total (N = 74) |
|---|---|---|---|
| Headache | 4 (14.8) | 3 (6.4) | 7 (9.5) |
| Nasopharyngitis | 3 (11.1) | 3 (6.4) | 6 (8.1) |
| Dizziness | 3 (11.1) | 2 (4.3) | 5 (6.8) |
| Influenza | 0 | 4 (8.5) | 4 (5.4) |
| Upper respiratory tract infection | 1 (3.7) | 3 (6.4) | 4 (5.4) |
| Anxiety | 1 (3.7) | 2 (4.3) | 3 (4.1) |
| Dysmenorrhea | 2 (7.4) | 1 (2.1) | 3 (4.1) |
| Rhinitis | 1 (3.7) | 2 (4.3) | 3 (4.1) |
| Abdominal pain | 0 | 2 (4.3) | 2 (2.7) |
| Diarrhea | 2 (7.4) | 0 | 2 (2.7) |
| Fatigue | 1 (3.7) | 1 (2.1) | 2 (2.7) |
| Nasal congestion | 0 | 2 (4.3) | 2 (2.7) |
| Oropharyngeal pain | 1 (3.7) | 1 (2.1) | 2 (2.7) |
| Urinary tract infection | 1 (3.7) | 1 (2.1) | 2 (2.7) |
OLE open-label extension, TEAE treatment-emergent adverse event