Table 3.

Safety assessment of the GMA in the five major special situation sub-groups with the incidence and 95% CI

		AE			ADE			FP
Patients/sub-group	Total	n	(%)	95% CI	n	(%)	95% CI	n	(%)	95% CI
Patients eligible for safety analysis	437	50	(11.4)		11	(2.5)		71	(16.2)
Patients who received GMA retreatment	131	13	(9.9)	0.054–0.164	3	(2.3)	0.008–0.076	11	(8.4)	0.043–0.145
Patients on multiple immunosuppressant medications	125	19	(15.2)	0.094–0.227	5	(4.0)	0.009–0.080	23	(18.4)	0.120–0.263
Elderly patients (≥65 years)	125	14	(11.2)	0.063–0.181	0	(0.0)	0.000–0.029	22	(17.6)	0.114–0.254
Patients with anaemia (haemoglobin < 10 g/dL)	105	19	(18.1)	0.113–0.268	4	(3.8)	0.016–0.108	22	(21.0)	0.136–0.300
Paediatric/adolescent patients (≤18 years)	53	10	(18.9)	0.094–0.320	3	(5.7)	0.021–0.182	11	(20.8)	0.108–0.341

GMA granulocyte and monocyte adsorptive apheresis, CI confidence interval, AE adverse event, ADE adverse device effect, FP feasibility problem