Table 2.

Consolidated overview of adverse events (AE) with GNbAC1 or placebo with a frequency >5% per group in healthy subjects and multiple sclerosis patients (SAE serious AE)

			Placebo (n = 12, 12 inj)		<2 mg/kg (n = 15, 15 inj)		2 mg/kg (n = 9, 51inj)		6 mg/kg (n = 9, 63inj)		All GNbAC1 (n = 33, 129 inj)
	System Organ Classes	Preferred Terms	n	%	n	%	n	%	n	%	n	%
SAE	Gastrointestinal disorder	pancreatitis	0	(0.0)	0	(0.0)	0	(0.0)	1	(11.1)	1	(3.0)
AE > 5%	Infections and infestations	Cystitis	0	(0.0)	0	(0.0)	2	(22.2)	1	(11.1)	3	(9.1)
		Nasopharyngitis	1	(8.3)	2	(13.3)	4	(44.4)	2	(22.2)	8	(24.2)
		Rhinitis	0	(0.0)	1	(6.7)	1	(11.1)	3	(33.3)	5	(15.2)
	Metabolism and nutrition disorders	Hyperglycaemia	0	(0.0)	0	(0.0)	0	(0.0)	2	(22.2)	2	(6.1)
	Nervous system disorder	Headache	1	(8.3)	1	(6.7)	3	(33.3)	2	(22.2)	5	(15.2)
		Spasm	0	(0.0)	0	(0.0)	2	(22.2)	1	(11.1)	3	(9.1)
	Cardiac disorders	Sinus bradycardia	0	(0.0)	0	(0.0)	2	(22.2)	2	(22.2)	4	(12.1)
	Respiratory, thoracic and mediastinal dis.	Oropharyngeal pain	0	(0.0)	1	(6.7)	1	(11.1)	2	(22.2)	4	(12.1)
	Gastrointestinal disorders	Nausea	0	(0.0)	1	(6.7)	0	(0.0)	1	(11.1)	2	(6.1)
	Renal and urinary disorders	Leukocyturia	0	(0.0)	0	(0.0)	1	(11.1)	2	(22.2)	3	(9.1)
		Proteinuria	0	(0.0)	0	(0.0)	1	(11.1)	2	(22.2)	3	(9.1)
	General disorders and admin.site cond.	Chest Pain	0	(0.0)	0	(0.0)	2	(22.2)	0	(0.0)	2	(6.1)
		Fatigue	0	(0.0)	0	(0.0)	1	(11.1)	3	(33.3)	4	(12.1)
		Gait disturbance	0	(0.0)	0	(0.0)	2	(22.2)	1	(11.1)	3	(9.1)
		Influenza-like illness	0	(0.0)	0	(0.0)	2	(22.2)	0	(0.0)	2	(6.1)
	Investigations	ECG QT prolonged	0	(0.0)	0	(0.0)	1	(11.1)	1	(11.1)	2	(6.1)
		Hyperglycemia	0	(0.0)	0	(0.0)	0	(0.0)	2	(22.2)	2	(6.1)
		gGT increased	0	(0.0)	0	(0.0)	2	(22.2)	1	(11.1)	3	(9.1)
	injury, poisoning, proced. complication	Hematoma	0	(0.0)	0	(0.0)	1	(11.1)	1	(11.1)	2	(6.1)
		Thermal burn	0	(0.0)	0	(0.0)	1	(11.1)	1	(11.1)	2	(6.1)