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. 2024 Aug 27;101(1):353–367. doi: 10.3233/JAD-240221

Table 7.

Signs and symptoms associated with injection site reactions in the OLE by previous randomization (safety-evaluable population)

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.