|
(N=458) |
(N=458) |
(N=37) |
(N=37) |
(N=421) |
(N=421) |
(N=471) |
(N=471) |
(N=35) |
(N=35) |
(N=436) |
(N=436) |
Subjects reporting |
N |
(%n) |
N |
(%n) |
N |
(n%) |
N |
(n%) |
N |
(%n) |
N |
(%n) |
Treatment emergent AEs |
289 |
(63%) |
22 |
(59%) |
267 |
(63%) |
402 |
(85%) |
29 |
(83%) |
373 |
(86%) |
AEs related to IMP |
144 |
(31%) |
10 |
(27%) |
134 |
(32%) |
373 |
(79%) |
28 |
(80%) |
345 |
(79%) |
Severe treatment emergent AEs |
12 |
(3%) |
1 |
(3%) |
11 |
(3%) |
39 |
(8%) |
2 |
(6%) |
37 |
(8%) |
Severe AEs related to IMP |
2 |
(<1%) |
1 |
(3%) |
1 |
(<1%) |
22 |
(5%) |
1 |
(3%) |
21 |
(5%) |
Serious treatment emergent AEs |
6 |
(1%) |
– |
– |
6 |
(1%) |
9 |
(2%) |
– |
– |
9 |
(2%) |
Serious AEs related to IMP |
1 |
(<1%) |
– |
– |
1 |
(<1%) |
1 |
(<1%) |
– |
– |
1 |
(<1%) |
Treatment emergent AEs leading to discontinuation |
11 |
(2%) |
– |
– |
11 |
(3%) |
39 |
(8%) |
1 |
(3%) |
38 |
(9%) |
AEs related to IMP leading to discontinuation |
8 |
(2%) |
– |
– |
8 |
(2%) |
33 |
(7%) |
1 |
(3%) |
32 |
(7%) |