Table 5 AEs possibly/probably related to icatibant, by system organ class and preferred terma
Patients | Elderly (≥ 65 years) (n = 100) | Younger (< 65 years) (n = 772) | Overall (n = 872) |
|---|---|---|---|
Any AE n (%) | 2 (2.0) | 21 (2.7) | 23 (2.6) |
General disorders and administration site conditions | 2 (2.0) | 15 (1.9) | 17 (1.9) |
Injection site erythema | 1 (1.0) | 9 (1.2) | 10 (1.1) |
Pain | 0 (0.0) | 3 (0.4) | 3 (0.3) |
Application site erythema | 0 (0.0) | 2 (0.3) | 2 (0.2) |
Application site pain | 0 (0.0) | 2 (0.3) | 2 (0.2) |
Infusion site pain | 1 (1.0) | 1 (0.1) | 2 (0.2) |
Drug ineffective | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Infusion site erythema | 1 (1.0) | 0 (0.0) | 1 (0.1) |
Injection site pain | 1 (1.0) | 0 (0.0) | 1 (0.1) |
Injection site hemorrhage | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Localized edema | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Non-cardiac chest pain | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Edema | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Therapeutic product ineffective | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Infusion site urticaria | 1 (1.0) | 0 (0.0) | 1 (0.1) |
Administration site reaction | 1 (1.0) | 0 (0.0) | 1 (0.1) |
Asthenia | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Vascular disorders | 0 (0.0) | 3 (0.4) | 3 (0.3) |
Hyperemia | 0 (0.0) | 2 (0.3) | 2 (0.2) |
Hot flush | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Skin and subcutaneous tissue disorders | 0 (0.0) | 3 (0.4) | 3 (0.3) |
Skin reaction | 0 (0.0) | 2 (0.3) | 2 (0.2) |
Angioedema | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Gastrointestinal disorders | 0 (0.0) | 4 (0.5) | 4 (0.5) |
Nausea | 0 (0.0) | 2 (0.3) | 2 (0.2) |
Abdominal distension | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Abdominal pain upper | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Reflux esophagitis | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Hiatus hernia | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Gastritis | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Nervous system disorders | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Post-herpetic neuralgia | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Investigations | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Blood pressure decreased | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Infections and infestations | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Herpes zoster | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Psychiatric disorders | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Depression | 0 (0.0) | 1 (0.1) | 1 (0.1) |