Table 2 List and distribution of adverse events
Adverse Events | Early start (n = 6) | Delayed start (n = 6) | Pilots (n = 2) | Consequence |
|---|---|---|---|---|
Procedural AEs | ||||
Dural puncture | 1 | 0 | 0 | Reoperation (n = 1) |
Lead misplacement | 2 | 0 | 0 | Reoperation (n = 2) |
Peri-operative pain | 1 | 0 | 0 | Inpatient additional day (n = 1) |
Oedema/swelling over the implantation site | 3 | 2 | 0 | Self-limited (n = 5) |
Peri-surgical increase in Parkinsonian symptoms | 3 | 6 | 0 | Self-limited (n = 9) |
AEs during the trial period | ||||
Falls requiring hospital contact | 1 (One fall during RCT, one during open phase) | 1 (One fall during RCT, one during open phase) | 1 | Two fractures of the proximal humerus (Early start) One Colles fracture (Pilots) |
