|
N = 132
|
N = 64
|
N = 19
|
N = 41
|
|
N (%)
|
N (%)
|
N (%)
|
N (%)
|
Nature of harm
| | | | |
- Reporting with numerical data per trial arm when considering
| | | | |
- All adverse events
|
115 (87)
|
52 (81)
|
15 (79)
|
39 (95)
|
- Events other than MAC(C)E1
|
66 (50)
|
32 (50)
|
8 (42)
|
20 (49)
|
Harm severity
| | | | |
- Reporting with numerical data per trial arm when considering
| | | | |
- All adverse events
|
114 (86)
|
52 (81)
|
15 (79)
|
39 (95)
|
- Events other than MAC(C)E1
|
17 (13)
| | | |
Relation of harm to treatment
|
4 (3)
|
2 (3)
|
1 (5)
|
1 (2)
|
Procedural complications
|
30 (23)
|
9 (14)
|
3 (16)
|
14 (34)
|