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