Efficacy and safety of a novel sodium picosulfate oral tablet in a randomized controlled trial for bowel preparation

Table 3 Adverse drug reactions of the DWJ1609 and oral sulfate tablet groups (safety analysis set), n (%)

	DWJ1609 group (n = 105)	Oral sulfate tablet group (n = 106)	P value1
Adverse drug reaction	19 (18.10)	35 (33.02)	0.013
Gastrointestinal disorders	16 (15.24)	27 (25.47)	0.065
Nausea	8 (7.62)	23 (21.70)	0.004
Vomiting	6 (5.71)	3 (2.83)	0.332
Abdominal distension	4 (3.81)	6 (5.66)	0.748
Diarrhea	1 (0.95)	0	0.498
Gastroesophageal reflux disease	1 (0.95)	0	0.498
Abdominal pain	0	1 (0.94)	1.000
Gastritis erosive	0	1 (0.94)	1.000
Nervous system disorders	3 (2.86)	12 (11.32)	0.017
Dizziness	2 (1.90)	5 (4.72)	0.445
Headache	1 (0.95)	9 (8.49)	0.019
Hypoaesthesia	0	1 (0.94)	1.000
General disorders and administration site conditions	0	2 (1.89)	0.498
Chest discomfort	0	1 (0.94)	1.000
Chills	0	1 (0.94)	1.000
Metabolism and nutrition disorders	0	1 (0.94)	1.000
Hyponatremia	0	1 (0.94)	1.000

¹Testing for between-group differences in categorical variables (χ² test or Fisher’s exact test, depending on expected cell counts).