| |
N = 132
|
N = 64
|
N = 19
|
N = 41
|
| |
N (%)
|
N (%)
|
N (%)
|
N (%)
|
|
Assessment of harm
| | | | |
|
- Nature of adverse events systematically collected when considering
| | | | |
|
- All adverse events
|
110 (83)
|
50 (78)
|
16 (84)
|
39 (95)
|
|
- Events other than MAC(C)E1
|
63 (48)
|
22 (34)
|
8 (42)
|
16 (39)
|
|
- Mode of data collection provided when considering
| | | | |
|
- All adverse events
|
29 (22)
|
17 (27)
|
5 (26)
|
6 (15)
|
|
- Events other than MAC(C)E1
|
13 (10)
| | | |
|
Definition of expected adverse event
|
47 (36)
|
27 (42)
|
2 (11)
|
14 (34)
|
|
Assessment by an adjudication committee
|
46 (35)
|
35 (55)
|
4 (21)
|
7 (17)
|
|
Length of follow-up specified
|
95 (72)
|
52 (81)
|
11 (58)
|
32 (78)
|
|
- < 1 month
|
3 (2)
|
1 (2)
|
0
|
2 (5)
|
|
- 6 months
|
32 (24)
|
14 (22)
|
7 (37)
|
11 (27)
|
|
- 7–11 months
|
27 (20)
|
21 (33)
|
1 (5)
|
5 (12)
|
|
- 12 months
|
28 (21)
|
14 (22)
|
1 (5)
|
13 (32)
|
|
- > 12 months
|
5 (4)
|
2 (3)
|
2 (11)
|
1 (2)
|
|
No duration specified
|
29 (22)
|
12 (19)
|
8 (42)
|
9 (22)
|
