Table 5.

Most frequent treatment-emergent adverse events in the safety population [N = 85] by preferred term [> 5.0%].

MedDRA preferred term, n [%]	TEAE	Follow-up AE
Headache	17 [20.0]	0 [0]
Colitis ulcerative	10 [11.8]	3 [4.2]
Poor venous access	9 [10.6]	0 [0]
C-reactive protein increased	7 [8.2]	0 [0]
Vascular access complicationa	7 [8.2]	0 [0]
Vascular procedure complication	6 [7.1]	0 [0]
Abdominal pain	5 [5.9]	0 [0]
Fatigue	5 [5.9]	0 [0]
Haemoglobin decreased	5 [5.9]	0 [0]

AE, adverse event; TEAE, treatment-emergent adverse event.

^aInability to cannulate or no flow