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Withdrawn from treatment and/or studya | 214 (99.5) | 273 (99.3) | 39 (100) | 66 (100) | 37 (100) | 56 (100) |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) |