Table 2.
Summary of TEAEs Occurring in at Least 2% of Subjects in Any Arm in the Pooled Phase 3 Studies (Safety Population)
| TEAE, no. of Patients (%) | Cycle 1 | Entire Study (Cycles 1–3*) | ||||
|---|---|---|---|---|---|---|
| Placebo (n = 256) | OnabotA 40 U (n = 608) | OnabotA 64 U (n = 313) | OnabotA 40 U (n = 692) | OnabotA 64 U (n = 746) | OnabotA Total (n = 1,144) | |
| Headache | 15 (5.9) | 57 (9.4) | 24 (7.7) | 73 (10.5) | 69 (9.2) | 135 (11.8) |
| Nasopharyngitis | 8 (3.1) | 30 (4.9) | 26 (8.3) | 48 (6.9) | 48 (6.4) | 95 (8.3) |
| Injection site bruising | 7 (2.7) | 35 (5.8) | 12 (3.8) | 45 (6.5) | 47 (6.3) | 85 (7.4) |
| URTI | 4 (1.6) | 13 (2.1) | 5 (1.6) | 21 (3.0) | 29 (3.9) | 49 (4.3) |
| Injection site hematoma | 3 (1.2) | 16 (2.6) | 11 (3.5) | 16 (2.3) | 34 (4.6) | 43 (3.8) |
| Sinusitis | 3 (1.2) | 13 (2.1) | 6 (1.9) | 19 (2.7) | 18 (2.4) | 37 (3.2) |
| Eyebrow ptosis | 0 (0) | 11 (1.8) | 2 (0.6) | 22 (3.2) | 9 (1.2) | 30 (2.6) |
| Influenza | 5 (2.0) | 8 (1.3) | 4 (1.3) | 13 (1.9) | 12 (1.6) | 25 (2.2) |
| Eyelid ptosis | 1 (0.4) | 12 (2.0) | 2 (0.6) | 15 (2.2) | 7 (0.9) | 21 (1.8) |
| Oral herpes | 6 (2.3) | 5 (0.8) | 4 (1.3) | 7 (1.0) | 11 (1.5) | 17 (1.5) |
*Includes subjects randomized to placebo or onabotA 40 U in cycle 1 who received onabotA 40 U or 64 U, respectively, in cycles 2 and 3.
OnabotA, onabotulinumtoxinA; TEAEs, treatment-emergent adverse events; URTI, upper respiratory tract infection.