Table VI.
Adverse events across all treatment areas, filtered by P ≤ .050 across all groups (DBPC population, treatment cycle 1, days 1-90)
| 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 | 282 (42.4) | 85 (36.0) | NS | NS | NS | NS | 273 (37.7) | 84 (26.7) | 122 (39.0) | 45 (28.8) | 1136 (33.1) | 395 (29.1) |
| Eyelid ptosis | 16 (2.4) | 0 | NS | NS | NS | NS | 15 (2.1) | 1 (0.3) | NS | NS | 34 (1.0) | 1 (0.1) |
| Eyelid sensory disorder | 21 (3.2) | 1 (0.4) | NS | NS | NS | NS | NS | NS | NS | NS | 25 (0.7) | 1 (0.1) |
| Skin tightness | NS | NS | NS | NS | NS | NS | 10 (1.4) | 0 | NS | NS | 22 (0.6) | 1 (0.1) |
| Brow ptosis | NS | NS | NS | NS | NS | NS | 11 (1.5) | 0 | NS | NS | 20 (0.6) | 0 |
| Eyelid edema | NS | NS | 5 (0.4) | 0 | NS | NS | NS | NS | NS | NS | 12 (0.3) | 0 |
| Diarrhea | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 7 (0.2) | 9 (0.7) |
| Facial pain | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 12 (0.3) | 0 |
| Lower RTI | NS | NS | 1 (0.1) | 3 (0.4) | NS | NS | NS | NS | NS | NS | 4 (0.1) | 6 (0.4) |
| Pneumonia | NS | NS | NS | NS | NS | NS | 0 | 2 (0.6) | NS | NS | 3 (0.1) | 5 (0.4) |
| Periodontitis | NS | NS | 0 | 2 (0.2) | NS | NS | NS | NS | NS | NS | 0 | 3 (0.2) |
| Adjustment disorder∗ | NS | NS | 0 | 1 (0.1) | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Back injury | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Diabetes mellitus | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Fibromyalgia | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Gastrointestinal infection | NS | NS | 0 | 1 (0.1) | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Leiomyoma | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Osteoarthritis | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Petechiae | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Skin indentation | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Varicose vein | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Injection site pruritus | 2 (0.3) | 4 (1.7) | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS |
| Rash | 0 | 3 (1.3) | NS | NS | NS | NS | NS | NS | NS | NS | 2 (0.1) | 4 (0.3) |
| Gastroesophageal reflux disease | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 1 (0.0) | 3 (0.2) |
| Visual impairment | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 0 | 2 (0.1) |
| Perioral dermatitis | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | 0 | 1 (0.1) |
| Neck pain | 0 | 2 (0.8) | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS |
| Injection site hemorrhage | NS | NS | 8 (0.6) | 1 (0.1) | NS | NS | NS | NS | NS | NS | NS | NS |
| Cough | NS | NS | 6 (0.5) | 0 | NS | NS | NS | NS | NS | NS | NS | NS |
| Arthropod bite | NS | NS | 4 (0.3) | 0 | NS | NS | NS | NS | NS | NS | NS | NS |
| Injection site paresthesia | NS | NS | 4 (0.3) | 0 | NS | NS | NS | NS | NS | NS | NS | NS |
| Upper RTI | NS | NS | NS | NS | NS | NS | N/A | N/A | NS | NS | NS | NS |
| Dermatitis | NS | NS | 0 | 3 (0.4) | NS | NS | NS | NS | NS | NS | NS | NS |
| Vision blurred | NS | NS | 0 | 3 (0.4) | NS | NS | NS | NS | NS | NS | NS | NS |
| Dermatitis contact | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS |
| Eye pain | NS | NS | 0 | 2 (0.2) | NS | NS | NS | NS | NS | NS | NS | NS |
| Large intestine polyp | NS | NS | 0 | 1 (0.1) | NS | NS | NS | NS | NS | NS | NS | NS |
| Toothache | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS |
| Oral herpes | NS | NS | NS | NS | NS | NS | NS | NS | 2 (0.6) | 5 (3.2) | NS | NS |
| Head discomfort | NS | NS | NS | NS | NS | NS | 10 (1.4) | 0 | NS | NS | NS | NS |
| Nasopharyngitis | N/A | N/A | NS | NS | NS | NS | NS | NS | 22 (7.0) | 3 (1.9) | NS | NS |
Included only statistically significant adverse events (P ≤ .050) across all treatment areas in the DBPC population. For overall DBPC population, GL, CFL, and FHL/GL treatment areas, statistical testing was based on a fixed-effects meta-analysis model using both the Peto method and the Mantel–Haenszel method. The minimum P value between the 2 methods was used. For GL/CFL and FHL/GL/CFL treatment areas, statistical testing was based on Fisher’s exact tests.
CFL, Crow’s feet lines; DBPC, double-blind placebo-controlled; FHL, forehead lines; GL, glabellar lines; N/A, not applicable; NS, not significant; OnabotA, onabotulinumtoxinA, RTI, respiratory tract infection.
With depressed mood.