Table 5.
Summary of adverse events through the 12-month follow up of study subjects.
| DTM SCS (N = 63) |
Conv-SCS (N = 58) |
Total (N = 121) |
||||
|---|---|---|---|---|---|---|
| # AEs | Subjects with AEs | # AEs | Subjects with AEs | # AEs | Subjects with AEs | |
| All study-related AEs | 19 | 13 (20.6%) | 9 | 7 (12.1%) | 28 | 20 (16.5%) |
| Study-related SAEs | 2 | 1 (1.6%) | 2 | 2 (3.4%) | 4 | 3 (2.5%) |
| Procedure-related AEs | 11 | 9 (14.3%) | 4 | 4 (6.9%) | 15 | 13 (10.7%) |
| Device-related AEs | 3 | 2 (3.2%) | 4 | 3 (5.2%) | 7 | 5 (4.1%) |
SAEs, serious adverse events; Study-related AE, any AE that is deemed to be related to the treatment by the investigator; Procedure-related AE, any study-related AE that is deemed to be related to the procedures associated with implanting the device; Device-related AE, any study-related AE that is deemed to be related to the functioning of the device.