Table 4.
Reports of AEs/ SAEs
Group | Severity | Total | Related | Probable | Possible | Unrelated | Reporting events (n) |
SPA | AE | 4 | 2* | 0 | 0 | 2† | 3 |
SAE | 5 | 0 | 0 | 1‡ | 4§ | 2 | |
Control | AE | 1 | 0 | 0 | 0 | 1 | 1 |
SAE | 0 | 0 | 0 | 0 | 0 | 0 |
*Events were: fall off chair at singing group; trap thumb between chairs at singing group (two different participants).
†Events were: falls at home (same participant).
‡Event was: fall.
§1×fall; 1×death (same participant); 1×fall, 1×lung infection (same participant).
AE, adverse event; SAE, serious AE.