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Table 4 AEs in icatibant-treated patients that were considered related to icatibant by investigators, by Preferred Term

From: Hereditary angioedema due to C1 inhibitor deficiency: real-world experience from the Icatibant Outcome Survey in Spain

  Spain
n = 95
Other countries
n = 498
  Patients, n (%) Events,
n
Patients, n (%) Events,
n
Any AE 34 (35.8) 95 144 (28.9) 302
Any icatibant-related AE 2 (2.1) 18 22 (4.4) 57
 Administration site reaction 1 (1.1) 4 0 0
 Infusion site pain 1 (1.1) 1 1 (0.2) 1
 Asthenia 1 (1.1) 7 0 0
 Hypersensitivity 1 (1.1) 6 0 0
 Infusion site erythema 0 0 11 (2.2) 22
 Hyperemia 0 0 3 (0.6) 4
 Application site erythema 0 0 3 (0.6) 3
 Pain 0 0 3 (0.6) 3
 Application site pain 0 0 2 (0.4) 3
 Drug ineffective 0 0 2 (0.4) 2
 Blood pressure decreased 0 0 1 (0.2) 4
 Gastritis 0 0 1 (0.2) 3
 Abdominal pain upper 0 0 1 (0.2) 1
 Hiatus hernia 0 0 1 (0.2) 1
 Nausea 0 0 1 (0.2) 1
 Injection site hemorrhage 0 0 1 (0.2) 1
 Injection site reaction 0 0 1 (0.2) 1
 Angioedema 0 0 1 (0.2) 1
 Localized edema 0 0 1 (0.2) 1
 Edema 0 0 1 (0.2) 1
 Therapeutic product ineffective 0 0 1 (0.2) 1
 Herpes zoster 0 0 1 (0.2) 1
 Depression 0 0 1 (0.2) 1
 Hot flush 0 0 1 (0.2) 1
Any serious AE 18 (18.9) 34 79 (15.9) 126
Any icatibant-related serious AE     
 Gastritis 0 0 1 (0.2) 1
 Angioedema 0 0 1 (0.2) 1a
  1. AE adverse event
  2. aTwo doses of icatibant were administered before this patient was hospitalized for 24 h; in the hospital, fresh frozen plasma was given, and the patient was discharged the following day without any sequelae