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Table 4 Treatment-emergent adverse events (TEAEs) reported during the course of the study by treatment group (safety population; N = 88)

From: A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children

  Lactulose PEG 4000
  (N = 44) (N = 44)
Any TEAE* 26 (59.1%) [55 events] 27 (61.4%) [80 events]
 Anal dilation 10 (22.7%) [14 events] 14 (31.8%) [11 events]
 Upper respiratory tract infections 9 (20.5%) [11 events] 9 (20.5%) [11 events]
 Anal fissure 5 (11.4%) [6 events] 9 (20.5%) [10 events]
 Faecaloma 7 (15.9%) [10 events] 5 (11.4%) [6 events]
 Hard faeces 4 (9.1%) [4 events] 3 (6.8%) [3 events]
 Anal skin tags 1 (2.3%) [2 events] 5 (11.4%) [5 events]
 Rhinorrhoea 1 (2.3%) [1 event] 3 (6.8%) [3 events]
 Vomiting None 3 (6.8%) [3 events]
Mild TEAEs 26 (59.1%) [53 events] 26 (59.1%) [72 events]
Moderate TEAEs 1 (2.3%) [2 events] 5 (11.4%) [8 events]
Severe TEAEs None None
TEAEs possibly or probably related to treatment 1 (2.3%) [2 events] 3 (6.8%) [3 events]
Serious TEAEs 1 (2.3%) [1 event] 2 (4.6%) [2 events]
TEAEs leading to death None None
TEAEs leading to treatment discontinuation None 2 (4.6%) [5 events]
  1. Data are presented as the number of patients (%), with the number of events given in square brackets. *Only individual events reported in more than two patients in either group are listed.