TABLE 1.
Summary of patient demographics and incidence of adjudicated AEs within 90 days of surgery*
| Factor | Trial Site | Total | ||||||
|---|---|---|---|---|---|---|---|---|
| Toronto | BAI | Brown | UF | JH | BSHRI | Penn | ||
| No. of patients | 12 | 9 | 6 | 5 | 4 | 4 | 2 | 42 |
| Sex (no. of patients) | ||||||||
| Female | 5 | 4 | 2 | 3 | 2 | 1 | 2 | 19 |
| Male | 7 | 5 | 4 | 3 | 2 | 3 | 0 | 23 |
| Age (yrs) | 68.7 ± 6.8 (52.9–77.1) | 71.1 ± 3.0 (66.7–74.9) | 75.3 ± 3.2 (71.6–79.7) | 62.7 ± 6.7 (57.1–72.9) | 60.3 ± 10.2 (48.0–72.7) | 64.8 ± 12.1 (51.1–78.0) | 66.1 ± 10.6 (58.6–73.6) | 68.2 ± 7.8 (48.0–79.7) |
| Duration of surgery (hrs) | 4.6 ± 1.7 | 2.7 ± 0.6 | 4.5 ± 0.3 | 6.4 ± 1.6 | 4.5 ± 0.7 | 2.6 ± 0.5 | 3.3 ± 0.4 | 4.1 ± 1.6 |
| Duration of hospitalization (days) | 1.3 ± 0.6 | 1.0 ± 0.0 | 1.2 ± 0.4 | 1.2 ± 0.4 | 3.3 ± 0.5 | 1.0 ± 0.0 | 2.0 ± 0.0 | 1.4 ± 0.8 |
| Interval from diagnosis (yrs) | 2.6 ± 1.2 (0.7–4.4) | 0.9 ± 0.8 (0.0–2.8) | 4.1 ± 1.5 (1.5–5.9) | 2.6 ± 2.1 (0.4–5.6) | 2.6 ± 2.5 (0.3–5.9) | 1.6 ± 1.5 (0.4–3.8) | 2.1 ± 2.0 (0.6–3.5) | 2.3 ± 1.7 (0.0–5.9) |
| No. of AEs | 8 | 17 | 20 | 2 | 6 | 2 | 9 | 64 |
| No. of SAEs | 2 | 1 | 1 | 1 | 2 | 0 | 0 | 7 |
BAI = Banner Alzheimer’s Institute; Brown = Brown University; BSHRI = Banner Sun Health Research Institute; JH = Johns Hopkins Bayview; Penn = Hospital of the University of Pennsylvania, Penn Memory Clinic; Toronto = Toronto Western Hospital; UF = University of Florida–Gainesville.
*
Data are presented as the mean ± SD (range), unless otherwise noted.