Table 1.
Summary of the safety assessment in each sub-group within the patients in special situations
| Number of patients | Number and (%) of patients | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Total | UC | CD | AE | sAE | ADE | FP | |||||
| Patients eligible for safety analysis | 437 | 368 | 69 | 50 | (11.4%) | 16 | (3.7%) | 11 | (2.5%) | 71 | (16.2%) |
| Patients who received GMA retreatment | 131 | 109 | 22 | 13 | (9.9%) | 3 | (2.3%) | 3 | (2.3%) | 11 | (8.4%) |
| Patients on multiple immunosuppressant medications | 125 | 95 | 30 | 19 | (15.2%) | 5 | (4.0%) | 5 | (4.0%) | 23 | (18.4%) |
| Elderly patients (≥ 65 years) | 125 | 118 | 7 | 14 | (11.2%) | 7 | (5.6%) | 0 | 22 | (17.6%) | |
| Anaemic patients (haemoglobin < 10 g/dL) | 105 | 89 | 16 | 19 | (18.1%) | 7 | (6.7%) | 4 | (3.8%) | 22 | (21.0%) |
| Paediatric/adolescent patients (≤ 18 years) | 53 | 40 | 13 | 10 | (18.9%) | 4 | (7.5%) | 3 | (5.7%) | 11 | (20.8%) |
| Patients with diabetes mellitus | 23 | 20 | 3 | 4 | (17.4%) | 1 | (4.3%) | 0 | 4 | (17.4%) | |
| Patients with ischaemic heart disease or arrhythmia | 20 | 19 | 1 | 4 | (20.0%) | 2 | (10.0%) | 0 | 4 | (20.0%) | |
| Patients with viral hepatitis | 19 | 18 | 1 | 3 | (15.8%) | 2 | (10.5%) | 0 | 6 | (31.6%) | |
| Patients with past or current malignancy | 19 | 16 | 3 | 1 | (5.3%) | 0 | 0 | 3 | (15.8%) | ||
| Patients with arrhythmia | 16 | 14 | 2 | 2 | (12.5%) | 1 | (6.3%) | 0 | 1 | (6.3%) | |
| Patients with hypertension | 16 | 16 | 0 | 2 | (12.5%) | 0 | 0 | 2 | (12.5%) | ||
| Patients with liver disorder | 15 | 14 | 1 | 5 | (33.3%) | 4 | (26.7%) | 0 | 1 | (6.7%) | |
| Patients with intestinal fistula | 14 | 0 | 14 | 2 | (14.3%) | 0 | 1 | (7.1%) | 2 | (14.3%) | |
| Patients infected by cytomegalovirus | 14 | 14 | 0 | 2 | (14.3%) | 1 | (7.1%) | 0 | 2 | (14.3%) | |
| Patients with renal disorder | 13 | 11 | 2 | 1 | (7.7%) | 1 | (7.7%) | 0 | 1 | (7.7%) | |
| Pregnant or lactating mothers | 12 | 12 | 0 | 0 | 0 | 0 | 1 | (8.3%) | |||
| Patients with pyoderma gangrenous | 9 | 7 | 2 | 0 | 0 | 0 | 1 | (11.1%) | |||
| Patients with dyslipidemia | 9 | 9 | 0 | 1 | (11.1%) | 0 | 0 | 0 | |||
| Patients refractory or intolerant to biologics | 8 | 5 | 3 | 0 | 0 | 0 | 1 | (12.5%) | |||
| Patients with erythema nodosum | 8 | 8 | 0 | 0 | 0 | 0 | 1 | (12.5%) | |||
| Patients intolerant to 5-aminosalicylates | 8 | 7 | 1 | 0 | 0 | 0 | 2 | (25.0%) | |||
| Patients with CD receiving GMA monotherapy | 8 | 0 | 8 | 1 | (12.5%) | 1 | (12.5%) | 0 | 2 | (25.0%) | |
| Patients with psychiatric disorders | 6 | 6 | 0 | 0 | 0 | 0 | 3 | (50.0%) | |||
| Patients with primary sclerosing cholangitis | 4 | 4 | 0 | 0 | 0 | 0 | 0 | ||||
| Patients allergic to anticoagulants | 4 | 4 | 0 | 3 | (75.0%) | 0 | 2 | (50.0%) | 3 | (75.0%) | |
| Patients with intestinal stenosis | 3 | 0 | 3 | 1 | (33.3%) | 0 | 1 | (33.3%) | 1 | (33.3%) | |
| Others | 12 | 11 | 1 | 3 | (13.6%) | 1 | (8.3%) | 1 | (8.3%) | 4 | (18.2%) |
UC ulcerative colitis, CD Crohn’s disease, AE adverse event, sAE serious adverse event, ADE adverse device effect, FP feasibility problem, GMA granulocyte and monocyte adsorptive apheresis