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Table 3 Safety/Tolerability

From: 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

  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 TEAEsa, 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 TEAEsb, 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
  1. 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%)