Table 5.
Serious adverse events
| Discontinuation (n = 101) | Usual care (n = 104) | ||
|---|---|---|---|
| Participants with reported SAE a (%) | 36 (35.6) | 25 (24.0) | |
| Cardiovascular SAE, n (%) | 9 (8.9) | 5 (4.8) | |
| Non-cardiovascular SAE, n (%) | 26 (25.7) | 18 (17.3) | |
| Not possible to determine, n (%) | 1 (1.0) | 2 (1.9) | |
| Time to SAE in days, median (IQR) | 135 (66–209) | 103 (54–171) | |
| Death, n (%) | 33 (32.7) | 23 (22.1) | |
| Cardiovascular, n (%) | 7 (6.9) | 5 (4.8) | |
| Non-cardiovascular, n (%) | 25 (24.8) | 16 (15.4) | |
| Not possible to determine, n (%) | 1 (1.0) | 2 (1.9) | |
| Time to death in days, median (IQR) | 134 (68–208) | 111 (56–173) | |
| Transient ischaemic attack, n (%) | 0 | 1 (1.0) | |
| Stroke, n (%) | 3 (3.0) | 1b(1.0) | |
| Myocardial infarction, n (%) | 2 (2.0) | 0 | |
| Hospitalisation, n (%) | 3 (3.0) | 1 (1.0) |
In total, 63 SAEs were reported in 61 participants, comprising 37 SAEs in 36 (35.6%) discontinuation group participants and 26 SAEs in 25 (24.0%) usual care group participants. IQR, interquartile range; SAE, serious adverse event.
aFor the two participants with multiple SAEs, the first SAE is included.
bOne lethal SAE was described as a COVID-19 infection or a secondary aspiration pneumonia after a preceding stroke.