Treatment-emergent adverse events determined to be possibly or probably related to velaglucerase alfa (GA-GCB) administration observed during the extension study (TKT 025Ext)
| System organ class preferred term . | Velaglucerase alfa (GA-GCB) 30-60 U/kg EOW . | |
|---|---|---|
| Patients, no. (%), n = 12 . | Events, no. (%), n = 101 . | |
| Any related adverse event nervous system disorders | 4 (40.0) | 7 (2.8) |
| Tremor | 1 (10.0) | 1 (0.32) |
| Respiratory, thoracic, and mediastinal disorders | ||
| Epistaxis | 2 (20.0) | 2 (0.6) |
| Gastrointestinal disorders | ||
| Abdominal pain | 2 (20.0) | 2 (0.6) |
| Musculoskeletal and connective tissue disorders | ||
| Pain in extremity | 1 (10.0) | 1 (0.3) |
| General disorders and administration site conditions | ||
| Fatigue | 1 (10.0) | 1 (0.3) |
| System organ class preferred term . | Velaglucerase alfa (GA-GCB) 30-60 U/kg EOW . | |
|---|---|---|
| Patients, no. (%), n = 12 . | Events, no. (%), n = 101 . | |
| Any related adverse event nervous system disorders | 4 (40.0) | 7 (2.8) |
| Tremor | 1 (10.0) | 1 (0.32) |
| Respiratory, thoracic, and mediastinal disorders | ||
| Epistaxis | 2 (20.0) | 2 (0.6) |
| Gastrointestinal disorders | ||
| Abdominal pain | 2 (20.0) | 2 (0.6) |
| Musculoskeletal and connective tissue disorders | ||
| Pain in extremity | 1 (10.0) | 1 (0.3) |
| General disorders and administration site conditions | ||
| Fatigue | 1 (10.0) | 1 (0.3) |
Percentages of patients are based on the total number of patients in the safety population. Percentage of events is based on the total number of events experienced by patients in the safety population. Adverse events are coded using the MedDRA Version 9.0 dictionary.
EOW indicates every other week.