Table 3.
Overview of AEs in the OLE by previous randomization (safety-evaluable population)
| Participants previously on placebo (n = 117) | Participants on gantenerumab (n = 108) | Total (N = 225) | |
| Administration-related reaction | 48 (41.0) | 44 (40.7) | 92 (41.0) |
| Total number of participants with at least one AE | 107 (91.5) | 103 (95.4) | 210 (93.3) |
| Any AE, n | 990 | 1038 | 2028 |
| Deaths | 5 (4.3) | 5 (4.6) | 10 (4.4) |
| Participants withdrawn from study due to an AE | 14 (12.0) | 17 (15.7) | 31 (13.8) |
| Any serious AE | 29 (24.8) | 41 (38.0) | 70 (31.1) |
| Any serious AE leading to withdrawal from treatment | 4 (3.4) | 6 (5.6) | 10 (4.4) |
| Any serious AE leading to dose modification/interruption | 7 (6.0) | 8 (7.4) | 15 (6.7) |
| Any related serious AE | 4 (3.4) | 7 (6.5) | 11 (4.9) |
| Any AE leading to withdrawal from treatment | 14 (12.0) | 17 (15.7) | 31 (13.8) |
| Any AE leading to dose modification/interruption | 32 (27.4) | 38 (35.2) | 70 (31.1) |
| Any related AE | 68 (58.1) | 68 (63.0) | 136 (60.4) |
| Any related AE leading to withdrawal from treatment | 10 (8.5) | 14 (13.0) | 24 (10.7) |
| Any related AE leading to dose modification/interruption | 23 (19.7) | 30 (27.8) | 53 (23.6) |
| Any severe AE | 22 (18.8) | 31 (28.7) | 53 (23.6) |
| Participants with at least one of the following: | |||
| ARIA-H AE | 19 (16.2) | 24 (22.2) | 43 (19.1) |
| ARIA-E AE | 31 (26.5) | 32 (29.6) | 63 (28.0) |
AE, adverse event; ARIA-E, amyloid-related imaging abnormalities-edema; ARIA-H, amyloid-related imaging abnormalities-hemorrhage; OLE, open-label extension.