Table 3.
Treatment-related AEs reported in MP and OLEX by preferred term (SES).
| MP | OLEX (3 injection cycles) | |||||
|---|---|---|---|---|---|---|
|
IncobotulinumtoxinA
(N = 104) |
Placebo
(N = 104) |
Cycle 2
(N = 202) |
Cycle 3
(N = 190) |
Cycle 4
(N = 184) |
Total
(N = 202) |
|
| Subjects with at least one AE, n (%) | 50 (48.1) | 51 (49.0) | 81 (40.1) | 66 (34.7) | 63 (34.2) | 131 (64.9) |
| Treatment-related AEs | ||||||
| Subjects with at least one treatment-related AE, n (%) | 6 (5.8) | 5 (4.8) | 4 (2.0) | 4 (2.1) | 8 (4.3) | 14 (6.9) |
| Muscular weakness | 2 (1.9) | 2 (1.9) | 1 (0.5) | 0 | 3 (1.6) | 3 (1.5) |
| Myalgia | 0 | 3 (2.9) | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Fall | 0 | 1 (1.0) | 2 (1.0) | 0 | 0 | 2 (1.0) |
| Constipation | 1 (1.0) | 0 | 1 (0.5) | 1 (0.5) | 0 | 2 (1.0) |
| Limb discomfort | 0 | 0 | 0 | 1 (0.5) | 1 (0.5) | 2 (1.0) |
| Blood creatine phosphokinase increased | 0 | 0 | 0 | 1 (0.5) | 1 (0.5) | 2 (1.0) |
| Pain in extremity | 0 | 1 (1.0) | 0 | 0 | 1 (0.5) | 1 (0.5) |
| Ligament sprain | 0 | 0 | 0 | 1 (0.5) | 0 | 1 (0.5) |
| Arthralgia | 0 | 0 | 0 | 0 | 1 (0.5) | 1 (0.5) |
| Malaise | 1 (1.0) | 0 | 0 | 0 | 0 | 0 |
| Cellulitis | 1 (1.0) | 0 | 0 | 0 | 0 | 0 |
| Post-micturition dribble | 1 (1.0) | 0 | 0 | 0 | 0 | 0 |
| Incontinence | 0 | 1 (1.0) | 0 | 0 | 0 | 0 |
| Neurogenic bladder | 0 | 1 (1.0) | 0 | 0 | 0 | 0 |
| Contusion | 0 | 1 (1.0) | 0 | 0 | 0 | 0 |
| Dizziness | 0 | 1 (1.0) | 0 | 0 | 0 | 0 |
| Pollakiuria | 0 | 0 | 0 | 0 | 1 (0.5) | 1 (0.5) |
| Urinary retention | 0 | 0 | 0 | 0 | 1 (0.5) | 1 (0.5) |
| Hemorrhage subcutaneous | 0 | 0 | 0 | 1 (0.5) | 0 | 1 (0.5) |
| Hyperkeratosis | 0 | 0 | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Paralysis | 0 | 0 | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Treatment-related AESIs | ||||||
| Subjects with at least one treatment-related AESI, n (%) | 3 (2.9%) | 2 (1.9) | 3 (1.5) | 1 (0.5) | 4 (2.2) | 7 (3.5) |
| Muscular weakness | 2 (1.9) | 2 (1.9) | 1 (0.5) | 0 | 3 (1.6) | 3 (1.5) |
| Constipation | 1 (1.0) | 0 | 1 (0.5) | 1 (0.5) | 0 | 2 (1.0) |
| Urinary retention | 0 | 0 | 0 | 0 | 1 (0.5) | 1 (0.5) |
| Paralysis | 0 | 0 | 1 (0.5) | 0 | 0 | 1 (0.5) |
AE, adverse event; AESI, adverse event of special interest; MP, main period; N, number of subjects in each group; n, number of subjects in the given category; OLEX, open-label extension period; SES, safety evaluation set.