Table 2.
Relationship | 2 μg | 4 μg | 6 μg | 8 μg | 12 μg | Placebo | |
---|---|---|---|---|---|---|---|
N = | 47 | 48 | 46 | 44 | 28 | 32 | |
Unsolicited | Any |
22 (47) |
32 (67) |
29 (63) |
28 (64) |
21 (75) |
14 (44) |
Related |
7 (15) |
19 (40) |
15 (33) |
18 (41) |
12 (43) |
4 (13) |
|
SAEs | Any | 3 (1.2)a | |||||
Related | 0 | ||||||
Medically attended AEs | Any |
2 (4.3) |
1 (2.1) |
4 (8.7) |
3 (6.8) |
4 (14.3) |
6 (18.8) |
AESI | Any | 0 | 0 | 0 | 0 | 0 | 0 |
Italicised numbers are percentages
aThe 3 unrelated SAEs are not shown by group to maintain blind for this interim analysis