Table 7.
Participants previously on placebo (n = 117) | Participants previously on gantenerumab (n = 108) | Total (N = 225) | |
Total number of participants with at least one sign or symptom associated with administration-related reactions, n (%) | 48 (41.0) | 44 (40.7) | 92 (40.9) |
Overall total number of events reported as a sign or symptom associated with administration-related reactions, n | 377 | 395 | 772 |
General disorders and administration site conditions | |||
Injection site erythema, n (%) | 41 (35.0) | 32 (29.6) | 73 (32.4) |
Injection site pruritus, n (%) | 10 (8.5) | 12 (11.1) | 22 (9.8) |
Injection site swelling, n (%) | 11 (9.4) | 6 (5.6) | 17 (7.6) |
Injection site induration, n (%) | 9 (7.7) | 3 (2.8) | 12 (5.3) |
Injection site rash, n (%) | 3 (2.6) | 5 (4.6) | 8 (3.6) |
Injection site pain, n (%) | 4 (3.4) | 3 (2.8) | 7 (3.1) |
Injection site bruising, n (%) | 1 (0.9) | 1 (0.9) | 2 (0.9) |
Injection site dermatitis, n (%) | 1 (0.9) | 1 (0.9) | 2 (0.9) |
Injection site discoloration, n (%) | 1 (0.9) | 1 (0.9) | 2 (0.9) |
Injection site hematoma, n (%) | 1 (0.9) | 1 (0.9) | 2 (0.9) |
Injection site inflammation, n (%) | 2 (1.7) | 0 | 2 (0.9) |
Injection site edema, n (%) | 1 (0.9) | 1 (0.9) | 2 (0.9) |
Injection site urticaria, n (%) | 1 (0.9) | 1 (0.9) | 1 (0.4) |
Injection site warmth, n (%) | 2 (1.7) | 0 | 1 (0.4) |
Infusion site inflammation, n (%) | 1 (0.9) | 0 | 1 (0.4) |
Infusion site pain, n (%) | 0 | 1 (0.9) | 1 (0.4) |
Injection site hemorrhage, n (%) | 1 (0.9) | 0 | 1 (0.4) |
Injection site irritation, n (%) | 1 (0.9) | 0 | 1 (0.4) |
Injection site macule, n (%) | 0 | 1 (0.9) | 1 (0.4) |
Injection site reaction, n (%) | 0 | 1 (0.9) | 1 (0.4) |
Skin and subcutaneous tissue disorders | |||
Pruritus, n (%) | 1 (0.9) | 0 | 1 (0.4) |
Rash erythematous, n (%) | 1 (0.9) | 0 | 1 (0.4) |
OLE, open-label extension.