Table 3.
Summary of AEs in the DBPC Period (Safety Population) and LTA Cycles (LTA Population)
| n (%) | DBPC period | LTA perioda | |||||
|---|---|---|---|---|---|---|---|
| AboBoNT-A solution 50 U (N = 126) | Placebo (N = 64) | Cycle 1 (N = 595) | Cycle 2 (N = 558) | Cycle 3 (N = 486) | Cycle 4 (N = 319) | Cycle 5 (N = 89) | |
| Any TEAEs | 51 (40.5) | 24 (37.5) | 270 (45.4) | 211 (37.8) | 162 (33.3) | 70 (21.9) | 19 (21.3) |
| Nasopharyngitis | 13 (10.3) | 8 (12.5) | 70 (11.8) | 79 (14.2) | 53 (10.9) | 18 (5.6) | 8 (9.0) |
| Headache | 13 (10.3) | 4 (6.3) | 78 (13.1) | 39 (7.0) | 27 (5.6) | 15 (4.7) | 2 (2.2) |
| Hematoma | 5 (4.0) | 0 | 8 (1.3) | 2 (0.4) | 5 (1.0) | 1 (0.3) | 1 (1.1) |
| Pharyngitis | 3 (2.4) | 0 | 6 (1.0) | 0 | 0 | 1 (0.3) | 0 |
| Vertigo | 3 (2.4) | 0 | 5 (0.8) | 1 (0.2) | 0 | 0 | 0 |
| Back pain | 2 (1.6) | 1 (1.6) | 13 (2.2) | 7 (1.3) | 4 (0.8) | 2 (0.6) | 0 |
| Any severe TEAEs | 0 | 1 (1.6) | 12 (2.0) | 17 (3.0) | 9 (1.9) | 4 (1.3) | 0 |
| Any related TEAEs | 15 (11.9) | 4 (6.3) | 75 (12.6) | 34 (6.1) | 22 (4.5) | 8 (2.5) | 4 (4.5) |
| Headache | 5 (4.0) | 3 (4.7) | 32 (5.4) | 16 (2.9) | 8 (1.6) | 3 (0.9) | 0 |
| Hematoma | 5 (4.0) | 0 | 7 (1.2) | 2 (0.4) | 4 (0.8) | 0 | 1 (1.1) |
| Eyelid edema | 2 (1.6) | 0 | 7 (1.2) | 3 (0.5) | 2 (0.4) | 1 (0.3) | 1 (1.1) |
| Eyelid ptosis | 0 | 0 | 8 (1.3) | 4 (0.7) | 2 (0.4) | 1 (0.3) | 0 |
| Any TEAEs leading to withdrawal | 0 | 0 | 2 (0.3) | 2 (0.4) | 0 | 0 | 0 |
| Any serious AEs | 1 (0.8) | 2 (3.1) | 9 (1.5) | 13 (2.3) | 5 (1.0) | 7 (2.2) | 0 |
AboBoNT-A, abobotulinumtoxinA; AE, adverse event; DBPC, double-blind placebo-controlled; LTA, long-term analysis; TEAE, treatment-emergent adverse event (TEAEs are reported for any events that occurred in ≥2% of patients at any treatment cycle; related TEAEs are reported for any events that occurred in ≥1% of patients at any treatment cycle).
aThis population of 595 patients consisted of 185 patients from the DBPC period (n = 126 treated with aboBoNT-A solution; n = 59 receiving placebo) and 410 additional patients recruited into open-label Cycle 1.