Treatment-emergent adverse events and infusion-related reactions within 2 hours of infusion
| Variable | Pegunigalsidase alfa | Agalsidase beta | ||||
| Male (n=29) | Female (n=23) | Overall (n=52) | Male (n=18) | Female (n=7) | Overall (n=25) | |
| Any TEAE* | ||||||
| Patient, n (%) | 25 (86) | 22 (96) | 47 (90) | 18 (100) | 6 (86) | 24 (96) |
| Events, n (rate*) | 294 (545) | 267 (605) | 561 (572) | 329 (922) | 77 (549) | 406 (817) |
| TEAE related to drug | ||||||
| Patient, n (%) | 15 (52) | 6 (26) | 21 (40) | 9 (50) | 2 (29) | 11 (44) |
| Events, n (rate*) | 33 (61) | 9 (20) | 42 (43) | 55 (154) | 21 (150) | 76 (153) |
| Serious TEAE related to drug | ||||||
| Patient, n (%) | 1 (3) | 0 (0) | 1 (2) | 0 (0) | 0 (0) | 0 (0) |
| Events, n (rate*) | 1 (2) | 0 (0) | 1 (1) | 0 (0) | 0 (0) | 0 (0) |
| TEAE leading to withdrawal | ||||||
| Patient, n (%) | 2 (7) | 0 (0) | 2 (4) | 0 (0) | 0 (0) | 0 (0) |
| Events, n (rate*) | 2 (4) | 0 (0) | 2 (2) | 0 (0) | 0 (0) | 0 (0) |
| Related TEAE leading to withdrawal | ||||||
| Patient, n (%) | 1 (3) | 0 (0) | 1 (2) | 0 (0) | 0 (0) | 0 (0) |
| Events, n (rate*) | 1 (2) | 0 (0) | 1 (1) | 0 (0) | 0 (0) | 0 (0) |
| Any infusion-related reactions | ||||||
| Patient, n (%) | 9 (31) | 2 (9) | 11 (21) | 5 (28) | 1 (14) | 6 (24) |
| Events, n (rate†) | 11 (0.8) | 2 (0.2) | 13 (0.5) | 33 (4) | 18 (5) | 51 (4) |
| Mild or moderate infusion-related reactions | ||||||
| Patient, n (%) | 9 (31) | 2 (9) | 11 (21) | 5 (28) | 1 (14) | 6 (24) |
| Events, n (rate†) | 10 (0.7) | 2 (0.2) | 12 (0.5) | 33 (4) | 18 (5) | 51 (4) |
| Severe infusion-related reactions | ||||||
| Patient, n (%) | 1 (3) | 0 (0) | 1 (2) | 0 (0) | 0 (0) | 0 (0) |
| Events, n (rate†) | 1 (0.1) | 0 (0) | 1 (0) | 0 (0) | 0 (0) | 0 (0) |
TEAEs include infusion-related reactions (defined as TEAEs beginning during or within 2 hours of infusion whose causality was assessed as definitely, probably or possibly treatment-related; these excluded injection site reactions, which were considered procedure-related).
*Per 100 exposure-years.
†Per 100 infusions.
TEAE, treatment-emergent adverse event.