Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean®) with a polyethylene glycol/bisacodyl kit

Table 5 Summary of treatment-emergent adverse events (safety analysis set), n (%)

Treatment-emergent adverse events	Quiklean®, n = 222	Klean-Prep/Dulcolax®, n = 220	P value
Any treatment-emergent adverse events	218 (98.2)	70 (31.8)	< 0.0001
Mild	217 (97.7)	70 (31.8)
Moderate	1 (0.5)	0
Severe	0	0
Life threatening	0	0
Death	0	0
MedDRA preferred term
Blood phosphorus increased	216 (97.3)	8 (3.6)	< 0.0001
Blood potassium decreased	109 (49.1)	9 (4.1)	< 0.0001
Blood phosphorus decreased	6 (2.7)	42 (19.1)	< 0.0001
Blood urea decreased	16 (7.2)	7 (3.2)	0.0847
Blood chloride decreased	14 (6.3)	8 (3.6)	0.2740
Blood chloride increased	6 (2.7)	7 (3.2)	0.7867
Blood calcium decreased	6 (2.7)	1 (0.5)	0.1221
Blood sodium decreased	7 (3.2)	0	0.0149
Blood creatinine decreased	2 (0.9)	1 (0.5)	1.0000
Blood urea increased	1 (0.5)	2 (0.9)	0.6224
Blood magnesium increased	2 (0.9)	0	0.4989
Blood sodium increased	1 (0.5)	1 (0.5)	1.0000
Blood creatinine increased	1 (0.5)	0	1.0000
Blood potassium increased	1 (0.5)	0	1.0000
Duodenal ulcer	0	1 (0.5)	0.4977
Nonalcoholic fatty liver disease	0	1 (0.5)	0.4977
Herpes zoster	0	1 (0.5)	0.4977
Pyoderma	0	1 (0.5)	0.4977
Muscle disorder	0	1 (0.5)	0.4977
Calculus urinary	1 (0.5)	0	1.0000
Asthma	1 (0.5)	0	1.0000
Rhinitis allergic	1 (0.5)	0	1.0000

P value: Between-group differences were compared using the Fisher’s exact test.