Table 2.
AE Summary (Safety Populationa)
| OL phasea | DB phase | Total n = 208 |
|||||
|---|---|---|---|---|---|---|---|
| Category, n (%) | 80 U n = 7 |
Placebo n = 25 |
20 U n = 50 |
40 U n = 50 |
60 U n = 49 |
80 U n = 52 |
|
| Subjects with ≥1 TEAE | 1 (14.3) | 2 (8.0) | 12 (24.0) | 14 (28.0) | 13 (26.5) | 12 (23.1) | 52 (25.0) |
| Headache | 0 | 0 | 2 | 3 | 7 | 1 | 13 (6.3) |
| Seasonal allergy | 0 | 1 | 0 | 3 | 2 | 1 | 6 (2.9) |
| Influenza | 0 | 1 | 2 | 2 | 1 | 0 | 5 (2.4) |
| URTI | 0 | 0 | 3 | 0 | 0 | 1 | 4 (1.9) |
| Bronchitis | 0 | 0 | 1 | 2 | 0 | 0 | 3 (1.4) |
| Any treatment-related AE | 1 (14.3) | 0 | 1 (2.0) | 2 (4.0) | 3 (6.1) | 3 (5.8) | 10 (4.8) |
| Headache | 0 | 0 | 0 | 2 | 3 | 1 | 6 (2.9) |
| Eyelid ptosis | 1 | 0 | 0 | 0 | 0 | 0 | 1 (0.5) |
| Contusion | 0 | 0 | 0 | 0 | 0 | 1 | 1 (0.5) |
| Brow ptosis | 0 | 0 | 1 | 0 | 0 | 0 | 1 (0.5) |
| Madarosis | 0 | 0 | 0 | 0 | 0 | 1 | 1 (0.5) |
| Serious AE | 0 | 0 | 0 | 0 | 1 (2.0) | 0 | 1 (0.5) |
| Cervical cancer | 0 | 0 | 0 | 0 | 1 | 0 | 1 (0.5) |
| AEs leading to study discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AE, adverse event; DB, double-blind; OL, open-label; TEAE, treatment-emergent adverse event; URTI, upper respiratory tract infection.
aAll subjects (N = 233) who received at least 1 injection (OL phase, n = 7; DB phase, n = 226).