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Table 3 The summary of treatment emergent adverse events and amyloid-related imaging abnormalities-edema (ARIA-E). Lecanemab was generally well-tolerated with similar incidence rates of AEs and SAEs between placebo and lecanemab, and these events were consistent with the subject population. The most common TEAEs were infusion-related reaction (most were mild to moderate in severity, most responded to prophylactic treatment, and few led to discontinuation) and ARIA-E (most were mild to moderate in severity, and were required to discontinue treatment, but encouraged to continue efficacy assessments). Incidence of treatment-related TEAE were similar for placebo and lecanemab for non-ARIA-E-related events

From: A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody

  Lecanemab
Category Placebo
(n = 245)
n (%)
2.5 mg/kg
Biweekly
(n = 52)
n (%)
5 mg/kg
Monthly
(n = 51)
n (%)
5 mg/kg
Biweekly
(n = 92)
n (%)
10 mg/kg
Monthly
(n = 253)
n (%)
10 mg/kg
Biweekly
(n = 161)
n (%)
Any TEAE 216 (88.2) 46 (88.5) 48 (94.1) 81 (88.0) 238 (94.1) 39 (86.3)
Treatment-related TEAE 65 (26.5) 23 (44.2) 25 (49.0) 31 (33.7) 135 (53.4) 76 (47.2)
Serious adverse event 43 (17.6) 10 (19.2) 4 (7.8) 16 (17.4) 31 (12.3) 25 (15.5)
Deaths 2 (0.8) 2 (3.8) 0 1 (1.1) 2 (0.8) 0
AE leading to discontinuation 15 (6.1) 7 (13.5) 4 (7.8) 10 (10.9) 47 (18.6) 24 (14.9)
ARIA-E 2 (0.8) 1 (1.9) 1 (2.0) 3 (3.3) 25 (9.9) 16 (9.9)
 ApoE4-positive (n = 436) 2 (1.1) 1 (2.6) 1 (2.5) 3 (3.6) 23 (10.2) 7 (14.3)
 ApoE4-negative(n = 112) 0 0 0 0 2 (7.1) 9 (8.0)
  1. TEAE, treatment emergent adverse event; ARIA-E, amyloid-related imaging abnormalities-edema; ApoE4, apolipoprotein E4