Table 1.
Patient disposition and exposure
| ApoE ε4 carriers | ApoE ε4 noncarriers | |||||
|---|---|---|---|---|---|---|
| PBO + BAP 0.5 | BAP 0.5 + BAP 0.5 | PBO + BAP 0.5 | BAP 0.5 + BAP 0.5 | PBO + BAP 1.0 | BAP 1.0 + BAP 1.0 | |
| Patients, n (%) | ||||||
| Randomized | 216 (100) | 276 (100) | 39 (100) | 66 (100) | 37 (100) | 56 (100) |
| Treated | 215 (99.5) | 275 (99.6) | 39 (100) | 66 (100) | 37 (100) | 56 (100) |
| Completeda | 1 (0.5) | 2 (0.7) | 0 | 0 | 0 | 0 |
| Withdrawn from treatment and/or studya | 214 (99.5) | 273 (99.3) | 39 (100) | 66 (100) | 37 (100) | 56 (100) |
| Primary reason for withdrawal from treatment (safety analysis population), n (%) | ||||||
| Unsatisfactory response-efficacy | 3 (1.4) | 6 (2.2) | 1 (2.6) | 1 (1.5) | 2 (5.4) | 2 (3.6) |
| Adverse event | 16 (7.4) | 11 (4.0) | 2 (5.1) | 5 (7.6) | 2 (5.4) | 6 (10.7) |
| Study termination | 163 (75.8) | 217 (78.9) | 31 (79.5) | 54 (81.8) | 30 (81.1) | 45 (80.4) |
| Subject request | 19 (8.8) | 25 (9.1) | 1 (2.6) | 4 (6.1) | 3 (8.1) | 3 (5.4) |
| Death | 3 (1.4) | 1 (0.4) | 0 | 0 | 0 | 0 |
| Recurrent episode of ARIA-E | 1 (0.5) | 0 | 0 | 0 | 0 | 0 |
| All other reasonsb | 9 (4.2) | 13 (4.7) | 4 (10.2) | 2 (3.0) | 0 | 0 |
| Person-years of study drug exposurec | ||||||
| N | 215 | 275 | 39 | 66 | 37 | 56 |
| Mean (SD) | 0.9 (0.58) | 1.0 (0.58) | 1.0 (0.53) | 1.0 (0.61) | 1.0 (5.4) | 1.0 (5.4) |
| Median (range) | 1 (0–3) | 1 (0–3) | 1 (0–2) | 1 (0–3) | 1 (0–2) | 1 (0–2) |
ApoE apolipoprotein E, ARIA-E amyloid-related imaging abnormalities with edema or effusions, BAP bapineuzumab, PBO placebo
aPercentage of treated patients
bIncludes investigator request, protocol violation, failed to return, lost to follow-up, loss of caregiver, other
cCalculated as the number of days for each individual patient from the day of the first infusion of the extension study through either the day of the last infusion plus 137 days or the day of last study visit plus 1 day, whichever is shorter, divided by 365.25