Table IV.
Adverse events occurring in ≥1% of participants occurring across all treatment areas (DBPC population)
| Preferred term, n (%) | GL |
CFL |
CFL/GL |
FHL/GL |
FHL/GL/CFL |
All |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OnabotA N = 665 |
Placebo N = 236 |
OnabotA N = 1324 |
Placebo N = 808 |
OnabotA N = 405 |
Placebo N = 306 |
OnabotA N = 724 |
Placebo N = 315 |
OnabotA N = 313 |
Placebo N = 156 |
OnabotA N = 3431 |
Placebo N = 1359 |
|
| Overall | 300 (45.1) | 94 (39.8) | 483 (36.5) | 293 (36.3) | 210 (51.9) | 136 (44.4) | 312 (43.1) | 99 (31.4) | 138 (44.1) | 52 (33.3) | 1443 (42.1) | 486 (35.8) |
| Headache | 75 (11.3) | 27 (11.4) | 50 (3.8) | 31 (3.8) | 32 (7.9) | 21 (6.9) | 62 (8.6) | 17 (5.4) | 24 (7.7) | 8 (5.1) | 243 (7.1) | 75 (5.5) |
| Nasopharyngitis | 40 (6.0) | 14 (5.9) | 82 (6.2) | 44 (5.4) | 29 (7.2) | 20 (6.5) | 35 (4.8) | 10 (3.2) | 26 (8.3) | 5 (3.2) | 212 (6.2) | 68 (5.0) |
| Injection site bruising | 2 (0.3) | 2 (0.8) | 35 (2.6) | 16 (2.0) | 20 (4.9) | 6 (2.0) | 37 (5.1) | 8 (2.5) | 12 (3.8) | 5 (3.2) | 106 (3.1) | 26 (1.9) |
| Upper RTI | 4 (0.6) | 2 (0.8) | 29 (2.2) | 17 (2.1) | 16 (4.0) | 11 (3.6) | 14 (1.9) | 5 (1.6) | 5 (1.6) | 1 (0.6) | 68 (2.0) | 24 (1.8) |
| Injection site hematoma | 0 (0.0) | 0 (0.0) | 25 (1.9) | 8 (1.0) | 14 (3.5) | 4 (1.3) | 16 (2.2) | 3 (1.0) | 11 (3.5) | 3 (1.9) | 66 (1.9) | 11 (0.8) |
| Sinusitis | 8 (1.2) | 3 (1.3) | 14 (1.1) | 13 (1.6) | 10 (2.5) | 7 (2.3) | 15 (2.1) | 4 (1.3) | 6 (1.9) | 3 (1.9) | 53 (1.5) | 20 (1.5) |
| Influenza | 10 (1.5) | 1 (0.4) | 15 (1.1) | 11 (1.4) | 5 (1.2) | 5 (1.6) | 74 (1.0) | 5 (1.6) | 4 (1.3) | 4 (2.6) | 41 (1.2) | 17 (1.3) |
| Bronchitis | 6 (0.9) | 3 (1.3) | 16 (1.2) | 9 (1.1) | 10 (2.5) | 6 (2.0) | 6 (0.8) | 0 (0.0) | 2 (0.6) | 0 (0.0) | 40 (1.2) | 12 (0.9) |
| Eyelid ptosis | 16 (2.4) | 0 (0.0) | 0 (0.0) | 1 (0.1) | 5 (1.2) | 1 (0.3) | 15 (2.1) | 1 (0.3) | 2 (0.6) | 1 (0.6) | 38 (1.1) | 2 (0.1) |
| Oral herpes | 0 (0.0) | 1 (0.4) | 15 (1.1) | 8 (1.0) | 4 (1.0) | 3 (1.0) | 7 (1.0) | 6 (1.9) | 4 (1.3) | 6 (3.8) | 30 (0.9) | 15 (1.1) |
| Injection site pain | 16 (2.4) | 4 (1.7) | 4 (0.3) | 6 (0.7) | 3 (0.7) | 3 (1.0) | 5 (0.7) | 3 (1.0) | 0 (0.0) | 0 (0.0) | 28 (0.8) | 13 (1.0) |
Included only adverse events with incidence of ≥1% in either treatment group across all treatment areas in the DBPC population.
CFL, Crow’s feet lines; DBPC, double-blind placebo-controlled; FHL, forehead lines; GL, glabellar lines; OnabotA, onabotulinumtoxinA; RTI, respiratory tract infection.