AE characterization by Initial visit 1 week 3 months 1 year
Total number of AEs per visit moment 441 255 98 26
Severity of AEs Severity of AEs Severity of AEs Severity of AEs Severity of AEs
Mild
343 (77.8)
149 (58.4)
50 (51.0)
12 (46.2)
Moderate
92 (20.9)
63 (24.7)
33 (33.7)
6 (23.1)
Severe
2 (0.5)
41 (16.1)
10 (10.2)
7 (26.9)
Unknown
4 (0.9)
2 (0.8)
5 (5.1)
1 (7.7)
Course / Outcome Course / Outcome Course / Outcome Course / Outcome Course / Outcome
Recovered
390 (88.4)
179 (70.2)
75 (76.5)
19 (73.1)
Recovered with residual symptoms
3 (0.7)
5 (2.0)
2 (2.0)
0 (0)
No recovery
8 (1.8)
23 (9.0)
4 (4.1)
1 (3.8)
Fatal
0 (0)
0 (0)
0 (0)
0 (0)
Unknown
40 (9.1)
48 (18.8)
17 (17.3)
6 (23.1)
Study drug adjustment Study drug adjustment Study drug adjustment Study drug adjustment Study drug adjustment
No
428 (97.1)
193 (75.7)
76 (77.6)
16 (61.5)
Temporary interrupted
6 (1.4)
15 (5.9)
8 (8.2)
0 (0)
Stopped
6 (1.4)
47 (18.4)
14 (14.3)
9 (34.6)
Unknown
1 (0.2)
0 (0)
0 (0)
1 (3.8)