Table VIII.
Adverse events by cycle occurring in ≥2 participants in the OnabotA group: maximum cycle analysis per treatment area
| Preferred term, n (%) | OnabotA: GL (n = 60) |
OnabotA: CFL (n = 82) |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | |
| Overall | 28 (46.7) | 21 (35.0) | 27 (45.0) | 27 (45.0) | 14 (23.3) | 16 (19.5) | 16 (19.5) | 27 (32.9) | 18 (22.0) | 8 (9.8) |
| Nasopharyngitis | 5 (8.3) | 11 (18.3) | 11 (18.3) | 10 (16.7) | 1 (1.7) | 4 (4.9) | 5 (6.1) | 11 (13.4) | 3 (3.7) | 1 (1.2) |
| Injection site pruritus | 5 (8.3) | 1 (1.7) | 0 | 0 | 0 | 1 (1.2) | 0 | 0 | 0 | 0 |
| Eyelid ptosis | 3 (5.0) | 0 | 1 (1.7) | 0 | 0 | 0 | 0 | 0 | 1 (1.2) | 1 (1.2) |
| Eyelid sensory disorder | 2 (3.3) | 1 (1.7) | 0 | 1 (1.7) | 0 | 1 (1.2) | 1 (1.2) | 0 | 0 | 0 |
| Headache | 2 (3.3) | 2 (3.3) | 0 | 0 | 1 (1.7) | 1 (1.2) | 1 (1.2) | 0 | 0 | 0 |
| Back pain | 2 (3.3) | 0 | 1 (1.7) | 1 (1.7) | 1 (1.7) | 0 | 0 | 1 (1.2) | 2 (2.4) | 0 |
| Blood creatine phosphokinase | 0 | 0 | 3 (5.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Influenza | 0 | 0 | 1 (1.7) | 2 (3.3) | 0 | 0 | 0 | 0 | 1 (1.2) | 0 |
| Seasonal allergy | 0 | 0 | 1 (1.7) | 3 (5.0) | 0 | 0 | 0 | 0 | 0 | 0 |
| Injection site hemorrhage | 0 | 0 | 0 | 0 | 0 | 2 (2.4) | 1 (1.2) | 1 (1.2) | 1 (1.2) | 1 (1.2) |
| Upper respiratory tract inflammation | 2 (3.3) | 1 (1.7) | 0 | 0 | 0 | 0 | 1 (1.2) | 0 | 1 (1.2) | 0 |
| Abdominal pain upper | 1 (1.7) | 0 | 2 (3.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Purpura | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (2.4) | 3 (3.7) | 1 (1.2) |
| Xeroderma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (2.4) | 0 | 0 |
| Blood cholesterol increased | 0 | 0 | 0 | 0 | 2 (3.3) | 0 | 0 | 0 | 0 | 0 |
| Eczema | 0 | 1 (1.7) | 0 | 2 (3.3) | 0 | 0 | 0 | 1 (1.2) | 0 | 0 |
| Rash | 1 (1.7) | 0 | 0 | 0 | 2 (3.3) | 0 | 0 | 0 | 0 | 0 |
OnabotA, OnabotulinumtoxinA.