Table 2.
Adverse events and ARIA in Clarity Core and Core + OLE
| Core | Core + OLE | ||
|---|---|---|---|
| Placebo (N = 897) n/N (%) | Lecanemab (N = 898) n/N (%) | Lecanemab (N = 1612) n/N (%) | |
| Any adverse event | 735 (81.9) | 798 (88.9) | 1389 (86.2) |
| Deaths | 7 (0.8) | 6 (0.7) | 16 (1.0)* |
| Serious adverse event (SAE) | 101 (11.3) | 126 (14.0) | 241 (15.0) |
| SAE with ARIA-E | 0 | 7 (0.8) | 18 (1.1) |
| SAE with ARIA-H | 0 | 2 (0.2) | 10 (0.6) |
| SAE with infusion-related reactions | 0 | 11 (1.2) | 20 (1.2) |
| Treatment-related adverse event | 197 (22.0) | 401 (44.7) | 721 (44.7) |
| Adverse event leading to drug withdrawal | 26 (2.9) | 62 (6.9) | 124 (7.7) |
| ARIA-E | 15/897 (1.7) | 113/898 (12.6) | 219/1612 (13.6) |
| ARIA-E by ApoE4 genotype | |||
| ApoE4 noncarrier | 1/286 (0.3) | 15/278 (5.4) | 32/496 (6.5) |
| ApoE4 carrier | 14/611 (2.3) | 98/620 (15.8) | 187/1116 (16.8) |
| ApoE4 heterozygote | 9/478 (1.9) | 52/479 (10.9) | 101/867 (11.6) |
| ApoE4 homozygote | 5/133 (3.8) | 46/141 (32.6) | 86/249 (34.5) |
| Symptomatic ARIA-E | 0 | 25/898 (2.8) | 54/1612 (3.3) |
| ApoE4 noncarrier | 0 | 4/278 (1.4) | 8/496 (1.6) |
| ApoE4 carrier | 0 | 21/620 (3.4) | 46/1116 (4.1) |
| ApoE4 heterozygote | 0 | 8/479 (1.7) | 18/867 (2.1) |
| ApoE4 homozygote | 0 | 13/141 (9.2) | 28/249 (11.2) |
| Recurrent ARIA-E | 1 (0.1) | 28 (3.1) | 46/1612 (2.9) |
| ApoE4 noncarrier | 0/286 (0) | 1/278 (0.4) | 4/496 (0.8) |
| ApoE4 carrier | 1/611 (0.2) | 27/620 (4.4) | 42/1116 (3.8) |
| ApoE4 heterozygote | 0/478 (0) | 7/479 (1.5) | 18/867 (2.1) |
| ApoE4 homozygote | 1/133 (0.8) | 20/141 (14.2) | 24/249 (9.6) |
| ARIA-H | 80 (8.9) | 152 (16.9) | 298/1612 (18.5) |
| Microhemorrhage | 68 (7.6) | 126 (14.0) | 258/1612 (16.0) |
| Superficial siderosis | 21 (2.3) | 50 (5.6) | 96/1612 (6.0) |
| Intracerebral hemorrhage | 1 (0.1) | 5 (0.6) | 8/1612 (0.5) |
| Symptomatic ARIA-H | 2 (0.2) | 11 (1.2) | 27/1612 (1.7) |
| ARIA-H by ApoE4 genotype | |||
| ApoE4 noncarrier, n/N (%) | 11/286 (3.8) | 32/278 (11.5) | 59/496 (11.9) |
| ApoE4 carrier, n/N (%) | 69/611 (11.3) | 120/620 (19.4) | 239/1116 (21.4) |
| ApoE4 heterozygote, n/N (%) | 41/478 (8.6) | 66/479 (13.8) | 140/867 (16.1) |
| ApoE4 homozygote, n/N (%) | 28/133 (21.1) | 54/141 (38.3) | 99/249 (39.8) |
| Isolated ARIA-H | 69 (7.7) | 78 (8.7) | 146 (9.1) |
| Microhemorrhage | 63 (7.0) | 60 (6.7) | 119 (7.4) |
| Superficial siderosis | 13 (1.4) | 23 (2.6) | 39 (2.4) |
| Isolated intracerebral hemorrhage | 1 (0.1) | 4 (0.4) | 5 (0.3) |
| Symptomatic isolated ARIA-H | 2 (0.2) | 4 (0.4) | 6 (0.4) |
| Isolated ARIA-H by ApoE4 genotype | |||
| ApoE4 noncarrier, n/N (%) | 10/286 (3.5) | 22/278 (7.9) | 38/496 (7.7) |
| ApoE4 carrier, n/N (%) | 59/611 (9.7) | 56/620 (9.0) | 108/1116 (9.7) |
| ApoE4 heterozygote, n/N (%) | 35/478 (7.3) | 39/479 (8.1) | 76/867 (8.8) |
| ApoE4 homozygote, n/N (%) | 24/133 (18.0) | 17/141 (12.1) | 32/249 (12.9) |
*The 16 deaths included 6 from Core, 9 from OLE, and one death that occurred > 30 days after last dose