Table 4.
GD-related events spontaneously reported during the whole period of imiglucerase supply constraint*
| GD Type 1 (N = 99) | ||
|---|---|---|
| Number of events | Number (%) of patients with at least 1 GD-related event | |
| All events | 64 | 39 (39.4%) |
| Bone events | 8 | 8 (8.1%) |
| Bone infarction | 4 | 4 (4.0%) |
| Osteonecrosis | 1 | 1 (1.0%) |
| Femur fracture | 1 | 1 (1.0%) |
| Hand fracture | 1 | 1 (1.0%) |
| Rib fracture | 1 | 1 (1.0%) |
| Other spontaneously reported events | ||
| Hematological events | 12 | 11 (11.1%) |
| Thrombocytopenia | 5 | 5 (5.1%) |
| Pancytopenia | 1 | 1 (1.0%) |
| Epistaxis | 3 | 3 (3.0%) |
| Gingival bleeding | 1 | 1 (1.0%) |
| Platelet count decreased | 1 | 1 (1.0%) |
| Haematoma | 1 | 1 (1.0%) |
| Visceral events | 4 | 3 (3.0%) |
| Hepatomegaly | 2 | 2 (2.0%) |
| Hepatosplenomegaly | 1 | 1 (1.0%) |
| Splenomegaly | 1 | 1 (1.0%) |
| Other frequent events (incidence ≥3%)* | 24 | 19 (19.2%) |
| Asthenia/Fatigue | 8 | 8 (8.1%) |
| Serum ferritin increased | 5 | 5 (5.1%) |
| Chitotriosidase increased | 4 | 4 (4.0%) |
| Bone pain | 4 | 4 (4.0%) |
| Osteopenia | 3 | 3 (3.0%) |
*Whole period of imiglucerase constraint refers to the period of time from first modification due to constraint to 31 October 2010).
Events are presented by MedDRA Preferred Term.
It should be noted that several events could be reported in one patient. During the considered period, a total of 64 events were reported in 39 patients: one event was reported in 26 patients, two events were reported in 5 patients, three events were reported in 4 patients and four events were reported in 4 patients.
*Sixteen other events (incidence <3%) were reported in a total of 12 patients (12.1%). These events were: tendonitis, angiotensin converted enzyme increased (2 patients each), arthralgia, back pain, coccydynia, musculoskeletal pain, thrombocytosis, increased blood acid phosphatase, Parkinson’s disease, sciatica, tremor, spontaneous abortion, stress, erectile dysfunction (1 patient each).