|
Source of data identified
|
37 (88%)
|
36 (86%)
|
20 (48%)
|
32 (76%)
|
|
Reporting of
|
|
Included participants
|
|
Number of participants randomised
|
37 (100%)
|
36 (100%)
|
19 (95%)
|
32 (100%)
|
|
Number of participants in safety population
|
37 (100%)
|
36 (100%)
|
19 (95%)
|
32 (100%)
|
|
Serious adverse events (SAEs)
|
|
Number of patients with at least one SAE
|
37 (100%)
|
36 (100%)
|
19 (95%)
|
16 (50%)
|
|
Total number of SAEs
|
9 (24%)
|
10 (28%)
|
17 (85%)
|
1 (3%)
|
|
Any adverse events (AEs)
|
|
Number of patients with at least one AE
|
37 (100%)
|
0 (0%)
|
0 (0%)
|
13 (41%)
|
|
Total number of AEs
|
12 (32%)
|
10 (28%)
|
17 (85%)
|
0 (0%)
|
|
CTCAE grade 3–5 AEs
|
|
Number of patients with at least one Grade 3–5 AE
|
36 (97%)
|
0 (0%)
|
0 (0%)
|
14 (44%)
|
|
Total number of Grade 3–5 AEs
|
6 (16%)
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
Deaths due to AEs
|
|
Number of deaths due to AEs
|
34 (92%)
|
0 (0%)
|
15 (75%)
|
12 (38%)
|
|
Information on how it was decided whether a death was considered due to an AE
|
10 (27%)
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
Discontinuations due to AEs
|
|
Number of patients who discontinued trial due to AEs
|
32 (86%)
|
28 (78%)
|
17 (85%)
|
25 (78%)
|
