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Table 1 Summary of the safety assessment in each sub-group within the patients in special situations

From: Safety and effectiveness of granulocyte and monocyte adsorptive apheresis in patients with inflammatory bowel disease in special situations: a multicentre cohort study

 Number of patientsNumber and (%) of patients
TotalUCCDAEsAEADEFP
Patients eligible for safety analysis4373686950(11.4%)16(3.7%)11(2.5%)71(16.2%)
Patients who received GMA retreatment1311092213(9.9%)3(2.3%)3(2.3%)11(8.4%)
Patients on multiple immunosuppressant medications125953019(15.2%)5(4.0%)5(4.0%)23(18.4%)
Elderly patients (≥ 65 years)125118714(11.2%)7(5.6%)0 22(17.6%)
Anaemic patients (haemoglobin < 10 g/dL)105891619(18.1%)7(6.7%)4(3.8%)22(21.0%)
Paediatric/adolescent patients (≤ 18 years)53401310(18.9%)4(7.5%)3(5.7%)11(20.8%)
Patients with diabetes mellitus232034(17.4%)1(4.3%)0 4(17.4%)
Patients with ischaemic heart disease or arrhythmia201914(20.0%)2(10.0%)0 4(20.0%)
Patients with viral hepatitis191813(15.8%)2(10.5%)0 6(31.6%)
Patients with past or current malignancy191631(5.3%)0 0 3(15.8%)
Patients with arrhythmia161422(12.5%)1(6.3%)0 1(6.3%)
Patients with hypertension161602(12.5%)0 0 2(12.5%)
Patients with liver disorder151415(33.3%)4(26.7%)0 1(6.7%)
Patients with intestinal fistula140142(14.3%)0 1(7.1%)2(14.3%)
Patients infected by cytomegalovirus141402(14.3%)1(7.1%)0 2(14.3%)
Patients with renal disorder131121(7.7%)1(7.7%)0 1(7.7%)
Pregnant or lactating mothers121200 0 0 1(8.3%)
Patients with pyoderma gangrenous9720 0 0 1(11.1%)
Patients with dyslipidemia9901(11.1%)0 0 0 
Patients refractory or intolerant to biologics8530 0 0 1(12.5%)
Patients with erythema nodosum8800 0 0 1(12.5%)
Patients intolerant to 5-aminosalicylates8710 0 0 2(25.0%)
Patients with CD receiving GMA monotherapy8081(12.5%)1(12.5%)0 2(25.0%)
Patients with psychiatric disorders6600 0 0 3(50.0%)
Patients with primary sclerosing cholangitis4400 0 0 0 
Patients allergic to anticoagulants4403(75.0%)0 2(50.0%)3(75.0%)
Patients with intestinal stenosis3031(33.3%)0 1(33.3%)1(33.3%)
Others121113(13.6%)1(8.3%)1(8.3%)4(18.2%)
  1. 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