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Table 1 Patient disposition and exposure

From: Long-term safety and tolerability of bapineuzumab in patients with Alzheimer’s disease in two phase 3 extension studies

  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Withdrawn from treatment and/or studya 214 (99.5) 273 (99.3) 39 (100) 66 (100) 37 (100) 56 (100)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)
  1. ApoE apolipoprotein E, ARIA-E amyloid-related imaging abnormalities with edema or effusions, BAP bapineuzumab, PBO placebo
  2. aPercentage of treated patients
  3. bIncludes investigator request, protocol violation, failed to return, lost to follow-up, loss of caregiver, other
  4. 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