Table 3.
Adverse eventsa
| Months 1–6 | Months 7–12 | Months 13–24 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Adverse event | BTX Subj (%) |
SNM Subj (%) |
p value | BTX Subj (%) |
SNM Subj (%) |
p value | BTX Subj (%) |
SNM Subj (%) |
p value |
| Urinary tract infection (per protocol) | 69 (36) | 27 (15) | <0.001 | 42 (22) | 21 (12) | 0.012 | 35 (18) | 15 (8) | 0.006 |
| Dysuria | 11 (6) | 2 (1) | 0.021 | 2 (1) | 1 (1) | 1.0 | 6 (3) | 2 (1) | 0.3 |
| GI issues (abdominal pain, diarrhea, constipation, nausea, vomiting) | 21 (11) | 17 (10) | 0.73 | 10 (5) | 10 (6) | 1.0 | 15 (8) | 5 (3) | 0.04 |
| Falls | 7 (4) | 11 (6) | 0.34 | 5 (3) | 8 (4) | 0.40 | 10 (5) | 14 (8) | 0.4 |
| Back pain | 10 (5) | 13 (7) | 0.52 | 4 (2) | 5 (3) | 0.74 | 3 (2) | 6 (3) | 0.3 |
| Arthralgia | 8 (4) | 8 (4) | 1.0 | 6 (3) | 6 (3) | 1.0 | 3 (2) | 7 (4) | 0.2 |
| Procedural pain | 14 (7) | 10 (6) | 0.53 | 3 (2%) | 0 (0) | 0.25 | 5 (3) | 0 (0) | 0.06 |
AE = adverse events; BTX = onabotulinumtoxinA; GI = gastrointestinal; SNM = sacral neuromodulation.
a
AE information was collected continuously over the study on a log form based on participant self-reported information. Analyses for these tables were based on the study safety population (all participants who received any study treatment grouped by actual treatment received, irrespective of amount or duration of treatment received) and included 191 participants on the BTX arm and 178 participants on the SNM arm. To partition AEs across time periods, the AE was classified as an incident event on the date that the event started.