Table 4.
Treatment-emergent adverse events
| TEAEs | Double-blind period | Open-label period | ||||||
|---|---|---|---|---|---|---|---|---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | ||||
| n, (%) | Group A | Group B | Group C | Group D | AboBoNT-A 50 U | AboBoNT-A 50 U | AboBoNT-A 50 U | AboBoNT-A 50 U |
| N = 326 | N = 66 | N = 107 | N = 21 | N = 465 | N = 385 | N = 244 | N = 102 | |
| Any TEAEs | 152 (46.6) | 14 (21.2) | 48 (44.9) | 4 (19.0) | 167 (35.9) | 129 (33.5) | 69 (28.3) | 21 (20.6) |
| Any treatment-related TEAEsa | 51 (15.6) | 0 | 13 (12.1) | 0 | 32 (6.9) | 19 (4.9) | 11 (4.5) | 1 (1.0) |
| Intensity of TEAEs | ||||||||
| Mild | 112 (34.4) | 11 (16.7) | 33 (30.8) | 4 (19.0) | 118 (25.4) | 97 (25.2) | 53 (21.7) | 19 (18.6) |
| Moderate | 35 (10.7) | 3 (4.5) | 10 (9.3) | 0 | 35 (7.5) | 28 (7.3) | 13 (5.3) | 2 (2.0) |
| Severe | 4 (1.2) | 0 | 3 (2.8) | 0 | 10 (2.2) | 1 (0.3) | 2 (0.8) | 0 |
| Missing | 1 (0.3) | 0 | 2 (1.9) | 0 | 4 (0.9) | 3 (0.8) | 1 (0.4) | 0 |
| Any serious TEAEs | 5 (1.5) | 2 (3.0) | 2 (1.9) | 0 | 16 (3.4) | 9 (2.3) | 5 (2.0) | 3 (2.9) |
| Any TEAEs leading to withdrawal | 0 | 0 | 2 (1.9) | 0 | 1 (0.2) | 1 (0.3) | 0 | 0 |
| Any TEAEs leading to death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs reported in ≥ 2% of patientsb,c | ||||||||
| Eye disorders | 32 (9.8) | 1 (1.5) | 7 (6.5) | 0 | 20 (4.3) | 14 (3.6) | 5 (2.0) | 3 (2.9) |
| Eyelid edema | 7 (2.1) | 0 | 1 (0.9) | 0 | 3 (0.6) | 2 (0.5) | 0 | 1 (1.0) |
| Eyelid ptosis | 13 (4.0) | 0 | 1 (0.9) | 0 | 9 (1.9) | 6 (1.6) | 1 (0.4) | 0 |
| Infections and infestations | 70 (21.5) | 9 (13.6) | 24 (22.4) | 0 | 78 (16.8) | 60 (15.6) | 28 (11.5) | 5 (4.9) |
| URTI | 29 (8.9) | 4 (6.1) | 12 (11.2) | 0 | 34 (7.3) | 33 (8.6) | 14 (5.7) | 3 (2.9) |
| Viral URTI | 15 (4.6) | 3 (4.5) | 4 (3.7) | 0 | 14 (3.0) | 9 (2.3) | 3 (1.2) | 0 |
| Metabolism and nutrition disorders | 7 (2.1) | 0 | 1 (0.9) | 0 | 4 (0.9) | 7 (1.8) | 3 (1.2) | 2 (2.0) |
| Hyperlipidemia | 5 (1.5) | 0 | 1 (0.9) | 0 | 3 (0.6) | 6 (1.6) | 2 (0.8) | 2 (2.0) |
| Nervous system disorders | 16 (4.9) | 0 | 2 (1.9) | 0 | 11 (2.4) | 11 (2.9) | 6 (2.5) | 0 |
| Headache | 9 (2.8) | 0 | 1 (0.9) | 0 | 3 (0.6) | 3 (0.8) | 4 (1.6) | 0 |
Data are shown for all randomized patients who received aboBoNT-A 50 U in at least one injection site regardless of the amount administered (safety population). aRelationship to study drug was assessed by the Investigator. bTEAEs with preferred term reported in ≥ 2% of patients treated with aboBoNT-A 50 U in any treatment cycle. cIf a patient experienced more than one event in a category, the patient is counted only once in that category. AboBoNT-A = abobotulinumtoxinA; Group A = patients who received aboBoNT-A 50 U; Group B = patients who received matching aboBoNT-A placebo; Group C = patients who received onaBoNT-A 20 U; Group D = patients who received matching onaBoNT-A placebo; N = number of total patients; n = number of patients with events; onaBoNT-A = onabotulinumtoxinA; SOC = system organ class; TEAE = treatment-emergent adverse event; U = unit; URTI = upper respiratory tract infection