Novel 1 L polyethylene glycol-based bowel preparation (NER1006): proof of concept assessment versus standard 2 L polyethylene glycol with ascorbate – a randomized, parallel group, phase 2, colonoscopist-blinded trial

Table 3 Safety/Tolerability

	LVPEG-1	LVPEG-2	LVPEG-3	Control	LVPEG-3	LVPEG-4	LVPEG-5	Control
Study Part	1	1	1	1	2	2	2	2
Patients, n	30	30	30	30	30	30	30	30
Subjects with TEAEs^a, n (%)	17 (56.7)	14 (46.7)	19 (63.3)	15 (50.0)	18 (60.0)	15 (50.0)	16 (53.3)	11 (36.7)
Subjects with TEAEs Leading to Withdrawal, n (%)	0	1 (3.3)	0	2 (6.67)	0	0	0	0
Number of Related TEAEs	29	24	35	28	24	25	24	15
Patients with Specific TEAEs^b, n (%)
Abdominal Discomfort	1 (3.3)	1 (3.3)	3 (10.0)	3 (10.0)	2 (6.7)	3 (10.0)	4 (13.3)	1 (3.3)
Abdominal Distension	0	0	2 (6.7)	4 (13.3)	0	2 (6.7)	1 (3.3)	1 (3.3)
Abdominal Pain	6 (20.0)	2 (6.7)	0	4 (13.3)	3 (10.0)	1 (3.3)	3 (10.0)	3 (10.0)
Nausea	6 (20.0)	8 (26.7)	10 (33.3)	7 (23.3)	6 (20.0)	5 (16.7)	3 (10.0)	3 (10.0)
Vomiting	1 (3.3)	3 (10.0)^c	1 (3.3)	1 (3.3)	1 (3.3)	1 (3.3)	0	0
Fatigue	0	0	1 (3.3)	0	2 (6.7)	0	1 (3.3)	1 (3.3)
Malaise	0	0	3 (10.0)	0	1 (3.3)	4 (13.3)	2 (6.7)	2 (6.7)
Thirst	0	0	1 (3.3)	0	2 (6.7)	0	0	0
Dizziness	2 (6.7)	1 (3.3)	0	0	1 (3.3)	3 (10.0)	1 (3.3)	0
Headache	7 (23.3)	4 (13.3)	6 (20.0)	4 (13.3)	5 (16.7)	3 (10.0)	3 (10.0)	6 (20.0)
Skin Irritation	0	2 (6.7)	2 (6.7)	0	0	0	0	0

TEAEs, treatment-emergent adverse events; MedDRA, Medical Dictionary for Regulatory Activities. ^aThere were no serious TEAEs or TEAEs leading to death. ^bReported with a frequency ≥ 5%. ^cOne subject was excluded from the vomiting rate analysis due to a protocol violation (compliance < 75%)

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