Table 3.
Summary of TEAEs up to Week 12 and over the full DBPC treatment cycle reported in ≥5% of patients in any treatment group by etiology
| SCI | MS | |||||
|---|---|---|---|---|---|---|
| TEAE | Placebo | AboBoNT‐A 600 U | AboBoNT‐A 800U | Placebo | AboBoNT‐A 600 U | AboBoNT‐A 800 U |
| (N = 112) | (N = 113) | (N = 114) | (N = 49) | (N = 47) | (N = 48) | |
| During first 12 weeks of DBPC cycle, n (%) | ||||||
| Any TEAE | 45 (40) | 54 (48) | 51 (45) | 21 (43) | 20 (43) | 17 (35) |
| Any serious TEAE | 4 (4) | 6 (5) | 5 (4) | 0 | 3 (6) | 1 (2) |
| TEAEs with incidence ≥5% in any group | ||||||
| UTIa | 17 (15) | 15 (13) | 18 (16) | 10 (20) | 8 (17) | 6 (13) |
| Hematuria | 4 (4) | 6 (5) | 3 (3) | 1 (2) | 1 (2) | 3 (6) |
| During full DBPC cycle, n (%) | ||||||
| Any TEAE | 53 (47) | 62 (55) | 62 (54) | 25 (51) | 26 (55) | 26 (54) |
| Any serious TEAE | 7 (6) | 11 (10) | 9 (8) | 1 (2) | 7 (15) | 5 (10) |
| TEAEs with incidence ≥5% in any group | ||||||
| UTIa | 21 (19) | 21 (19) | 30 (26) | 11 (22) | 12 (26) | 14 (29) |
| Bacteriuria | 0 | 3 (3) | 0 | 0 | 3 (6) | 1 (2) |
| Hematuria | 4 (4) | 8 (7) | 3 (3) | 1 (2) | 1 (2) | 3 (6) |
| Prior UTIb | 15 (13) | 20 (18) | 26 (23) | 10 (20) | 8 (17) | 12 (26) |
Note: Data shown are for the pooled safety population (DBPC period).
Abbreviations: AboBoNT‐A, abobotulinumtoxinA; DBPC, double‐blind placebo‐controlled; NDOI, neurogenic detrusor overactivity incontinence; N, number of patients in treatment group; n, number of patients with event; TEAE, treatment‐emergent adverse event; U, units; UTI, urinary tract infection.
UTI was defined as a positive urine culture result with a bacteriuria count of >105 colony forming unit/mL, leukocyturia of >5/high power field and symptoms suggestive of a UTI (may be atypical symptoms in NDOI population). If a patient experienced more than one event in a category, the patient is counted only once in that category.
Within 6 months before screening.