|
Adverse events * |
||||
| Months 0–12 post- procedure |
Months 13–24 post- procedure |
|||
|
|
|
|||
| SCS |
PMR |
SCS |
PMR |
|
|
|
||||
| Disease-related |
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| Unstable angina |
16 (10) |
16 (7) |
7 (5) |
12 (4) |
| Myocardial infarction |
4 (3) |
1 (1) |
1 (1) |
1 (1) |
| Loss of pain relief/angina worse |
5 (5) |
3 (2) |
3 (3) |
8 (6) |
| Total disease related |
25 (18) |
20 (10) |
11 (9) |
21 (11) |
| SCS related: Infection of SCS system |
0 |
NA |
0 |
2 (2) |
| Undesirable change in stimulation |
7 (5) |
NA |
5 (5) |
2 (1) |
| Pain at neurostimulator site |
5 (3) |
NA |
0 |
0 |
| Neurostimulator migration |
2 (2) |
NA |
1 (1) |
0 |
| Lead migration |
1 (1) |
NA |
0 |
0 |
| PMR related: Femoral pseudoaneurysm |
0 |
1 (1) |
0 |
0 |
| Groin haematoma |
1 (1) |
2 (2) |
0 |
0 |
| Other |
4 (3) |
7 (7) |
7 (5) |
4 (4) |
| Total |
45 (17) |
30 (15) |
24 (18) |
29 (12) |
| Total excluding SCS/PMR related |
29 (14) |
27 (14) |
18 (12) |
25 (11) |
| Severity |
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| Mild |
2 (2) |
2 (2) |
0 |
0 |
| Moderate |
5 (5) |
0 |
0 |
3 (2) |
| Severe** |
38 (15) |
28 (15) |
24 (18) |
26 (11) |
| Total |
45 (17) |
30 (15) |
24 (18) |
29 (12) |
|
*Data are number of events (number of patients), NA means Not Applicable. **Severe included events which: required hospital admission and/or surgery, prolonged hospital stay, or were life-threatening or fatal. | ||||
Dyer et al. Trials 2008 9:40 doi:10.1186/1745-6215-9-40 |
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