Table 4.
TEAEs with Onset Prior to or After Repeat Volux Treatment (Safety Population; n = 119)
| TEAE, n (%) | ||||
|---|---|---|---|---|
| Prior to repeat treatment | After repeat treatment | |||
| All treated subjects (n = 119) | Events (n = 98) | All treated subjects (n = 89) | Events (n = 57) | |
| Any TEAE | 46 (38.7) | 98 (100.0) | 18 (20.2) | 53 (100) |
| TEAE at injection site | 43 (36.1) | 91 (92.9) | 18 (20.2) | 53 (100) |
| Injection site mass | 26 (21.8) | 26 (26.5) | 13 (14.6) | 13 (24.5) |
| Injection site induration | 15 (12.6) | 21 (21.4) | 12 (13.5) | 12 (22.6) |
| Injection site pain | 15 (12.6) | 21 (21.4) | 7 (7.9) | 11 (20.8) |
| Injection site swelling | 7 (5.9) | 7 (7.1) | 4 (4.5) | 4 (7.5) |
| Injection site erythema | 6 (5.0) | 6 (6.1) | 4 (4.5) | 4 (7.5) |
| Injection site discoloration | 4 (3.4) | 4 (4.1) | 3 (3.4) | 3 (5.7) |
| Injection site pruritus | 4 (3.4) | 4 (4.1) | 2 (2.2) | 2 (3.8) |
| Speech disorder | 4 (3.4) | 6 (6.1) | 1 (1.1) | 1 (1.9) |
| Headache | 2 (1.7) | 2 (4.4) | 0 | 0 |
| Injection site nodule | 2 (1.7) | 2 (4.4) | 0 | 0 |
| Injection site bruising | 1 (0.8) | 1 (2.2) | 1 (1.1) | 1 (1.9) |
| Presyncope | 1 (0.8) | 1 (2.2) | 0 | 0 |
| Myalgia | 1 (0.8) | 1 (2.2) | 0 | 0 |
| Device dislocation | 1 (0.8) | 1 (2.2) | 0 | 0 |
| Injection site hematoma | 0 | 0 | 1 (1.1) | 1 (1.9) |
| Injection site abscess | 0 | 0 | 1 (1.1) | 1 (1.9) |
TEAE, treatment-emergent adverse event.