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