Treatment-emergent adverse events determined to be possibly or probably related to velaglucerase alfa (GA-GCB) administration observed during the phase 1/2 trial (TKT025)
| System organ class preferred term . | Velaglucerase alfa (GA-GCB) 60 U/kg EOW . | |
|---|---|---|
| Patients, no. (%), n = 12 . | Events, no. (%), n = 101 . | |
| Any related adverse event nervous system disorders | 10 (83.3) | 22 (21.8) |
| Dizziness | 3 (25.0) | 4 (4.0) |
| Headache | 2 (16.7) | 2 (2.0) |
| Burning sensation | 1 (8.3) | 1 (1.0) |
| Migraine | 1 (8.3) | 3 (3.0) |
| Tremor | 1 (8.3) | 1 (1.0) |
| Gastrointestinal disorders | ||
| Nausea | 2 (16.7) | 2 (2.0) |
| Upper abdominal pain | 1 (8.3) | 1 (1.0) |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 2 (16.7) | 2 (2.0) |
| Bone pain | 2 (16.7) | 2 (2.0) |
| Pain in extremity | 1 (8.3) | 1 (1.0) |
| General disorders and administration site conditions | ||
| Asthenia | 1 (8.3) | 1 (1.0) |
| Investigations | ||
| Body temperature increased | 2 (16.7) | 2 (2.0) |
| System organ class preferred term . | Velaglucerase alfa (GA-GCB) 60 U/kg EOW . | |
|---|---|---|
| Patients, no. (%), n = 12 . | Events, no. (%), n = 101 . | |
| Any related adverse event nervous system disorders | 10 (83.3) | 22 (21.8) |
| Dizziness | 3 (25.0) | 4 (4.0) |
| Headache | 2 (16.7) | 2 (2.0) |
| Burning sensation | 1 (8.3) | 1 (1.0) |
| Migraine | 1 (8.3) | 3 (3.0) |
| Tremor | 1 (8.3) | 1 (1.0) |
| Gastrointestinal disorders | ||
| Nausea | 2 (16.7) | 2 (2.0) |
| Upper abdominal pain | 1 (8.3) | 1 (1.0) |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 2 (16.7) | 2 (2.0) |
| Bone pain | 2 (16.7) | 2 (2.0) |
| Pain in extremity | 1 (8.3) | 1 (1.0) |
| General disorders and administration site conditions | ||
| Asthenia | 1 (8.3) | 1 (1.0) |
| Investigations | ||
| Body temperature increased | 2 (16.7) | 2 (2.0) |
Percentages of patients are based on the total number of patients in the treatment group. Adverse events are coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 7.0. MedDRA was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee.
EOW indicates every other week.