AEs of interest | Other AEs | SAEs | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Infusion pump | Manual | Infusion pump | Manual | Infusion pump | Manual | |||||||
Patients, n (%) (N = 71) |
AEs, n | Patients, n (%) (N = 54) |
AEs, n | Patients, n (%) (N = 71) |
AEs, n | Patients, n (%) (N = 54) |
AEs, n | Patients, n (%) (N = 71) |
AEs, n | Patients, n (%) (N = 54) |
AEs, n | |
Any AE | 6 (8.5) | 9 | 9 (16.7) | 11 | 12 (16.9) | 13 | 8 (14.8) | 16 | 5 (7.0) | 5 | 0 | 0 |
Severity of AE | ||||||||||||
Mild | 4 (5.6) | 7 | 6 (11.1) | 6 | 6 (8.5) | 7 | 5 (9.3) | 7 | 0 | 0 | 0 | 0 |
Moderate | 1 (1.4) | 1 | 4 (7.4) | 5 | 3 (4.2) | 3 | 3 (5.6) | 9 | 1 (1.4) | 1 | 0 | 0 |
Severe | 1 (1.4) | 1 | 0 | 0 | 3 (4.2) | 3 | 0 | 0 | 4 (5.6) | 4 | 0 | 0 |
AEs considered related to Ig20Gly | ||||||||||||
Related | 3 (4.2) | 3 | 4 (7.4) | 5 | 2 (2.8) | 3 | 1 (1.9) | 1 | 0 | 0 | 0 | 0 |
Possibly related | 2 (2.8) | 2 | 3 (5.6) | 3 | 2 (2.8) | 2 | 2 (3.7) | 4 | 1 (1.4) | 1 | 0 | 0 |
Probably related | 1 (1.4) | 1 | 1 (1.9) | 1 | 0 | 0 | 2 (3.7) | 2 | 0 | 0 | 0 | 0 |