Table 5.

Summary of adverse events through week 24

	Lupuzor
	Group 1 (200 μg every 4 weeks)	Group 2 (200 μg every 2 weeks)	Group 3 (placebo)
Patients treated, n	49	51	49
Patients with ≥1 AE, n (%)	20 (40.8)	21 (40.4)	24 (49.0)
AEs that occurred in ≥5% of patients in any treatment group
Drop-outs owing to AEs	1 (2.0)	0 (0.0)	4 (8.2)
Injection-site erythema, n (%)	3 (6.1)	5 (9.6)	1 (2.0)
Urinary tract infection, n (%)	2 (4.1)	2 (3.8)	5 (10.2)
Headache, n (%)	2 (4.1)	3 (5.8)	0 (0.0)
Nasopharyngitis, n (%)	1 (2.0)	4 (7.7)	0 (0.0)
Bronchitis, n (%)	3 (6.1)	1 (1.9)	0 (0.0)
Diarrhoea, n (%)	2 (4.1)	0 (0.0)	3 (6.1)
Pharyngitis, n (%)	1 (2.0)	0 (0.0)	3 (6.1)
	3 (6.1)	1 (1.9)	3 (6.1)
Patients with ≥1 serious AE, n (%)
Pneumonia, n (%)	1 (2.0)	0 (0.0)	2 (4.1)
Viral pneumonia (herpes), n (%)	0 (0.0)	1 (1.9)	0 (0.0)
Soft-tissue infection, n (%)	1 (2.0)	0 (0.0)	0 (0.0)
Diverticulitis, n (%)	0 (0.0)	0 (0.0)	1 (2.0)
Gastritis, n (%)	1 (2.0)	0 (0.0)	0 (0.0)
Deaths, n (%)*	1 (2.0)	0 (0.0)	0 (0.0)

*The fatal case was considered by the investigator as unrelated to the investigational product.

AE, adverse event.