Table 4.
Overall summary of AEs
Elderly (≥ 65 years) | Younger (< 65 years) | |||
---|---|---|---|---|
Patients (n = 100) | Events | Patients (n = 772) | Events | |
Total AEs, n (%) | 28 (28.0) | 86 (100.0) | 164 (21.2) | 374 (100.0) |
Occurrence of ≥ 1 icatibant-related AE, n (%) | 2 (2.0) | 19 (22.1) | 21 (2.7) | 68 (18.2) |
AEs by relationship to icatibant use, n (%) | ||||
Not recorded | 0 (0.0) | 0 (0.0) | 11 (1.4) | 28 (7.5) |
Not related | 26 (26.0) | 67 (77.9) | 132 (17.1) | 278 (74.3) |
Possibly related | 0 (0.0) | 0 (0.0) | 5 (0.6) | 34 (9.1) |
Probably related | 2 (2.0) | 19 (22.1) | 16 (2.1) | 34 (9.1) |
Icatibant-related AEs by seriousness, n (%) | ||||
Serious | 0 (0.0) | 0 (0.0) | 2 (0.3) | 3 (4.4) |
Not serious | 2 (2.0) | 19 (100.0) | 19 (2.5) | 65 (95.6) |
AE adverse event