Discrepancies
|
Number of patients with at least one SAE
|
15/32 trials (47%)
|
5/13 trials (38%)
|
8/14 trials (57%)
|
Total number of SAEs
|
5/5 trials (100%)
|
0/1 trial (0%)
|
No trials with data from both sources
|
Number of patients with at least one AE
|
No trials with data from both sources
|
2/11 trials (18%)
|
No trials with data from both sources
|
Total number of AEs
|
5/5 trials (100%)
|
No trials with data from both sources
|
No trials with data from both sources
|
Number of patients with at least one Grade 3–5 AE
|
No trials with data from both sources
|
7/12 trials (58%)
|
No trials with data from both sources
|
Total number of Grade 3–5 AEs
|
No trials with data from both sources
|
No trials with data from both sources
|
No trials with data from both sources
|
Number of deaths due to AEs
|
12/13 trials (92%)
|
4/10 trials (40%)
|
4/4 trials (100%)
|
Number of patients who discontinued trial due to AEs
|
23/26 trials (88%)
|
18/20 trials (90%)
|
11/18 trials (61%)
|