Pediatric bowel preparation: Sodium picosulfate, magnesium oxide, citric acid vs polyethylene glycol, a randomized trial

Table 2 Summary of adverse events, safety population

	9-12 yr old			13-16 yr old		All SPMC 1 dose × 2 (n = 33)	All PEG (n = 27)
n (%)	SPMC ½ dose × 2 (n = 15)	SPMC 1 dose × 2 (n = 17)	PEG (n = 15)	SPMC 1 dose × 2 (n = 16)	PEG (n = 12)
Any TEAE	8 (53.3)	5 (29.4)	6 (40.0)	10 (62.5)	11 (91.7)	15 (45.5)	17 (63.0)
Deaths	0	0	0	0	0	0	0
Serious TEAE	0	0	0	0	0	0	0
TEAE leading to study discontinuation	0	0	0	0	0	0	0
Severe AE	0	0	0	1 (6.3)	0	1 (3.0)	0
ADR	1 (6.7)	0	1 (6.7)	4 (25.0)	4 (33.3)	4 (12.1)	5 (18.5)
Nausea	1 (6.7)	0	1 (6.7)	1 (6.3)	3 (25.0)	1 (3.0)	4 (14.8)
Vomiting	1 (6.7)	0	0	2 (12.5)	1 (8.3)	2 (6.1)	1 (3.7)
Abdominal pain	0	0	0	1 (6.3)	0	1 (3.0)	0
Retching	0	0	0	1 (6.3)	0	1 (3.0)	0
Migraine	1 (6.7)	0	0	0	0	0	0
Hyperhidrosis	0	0	0	1 (6.3)	0	1 (3.0)	0
Serious ADR	0	0	0	0	0	0	0

SPMC: Sodium picosulfate, magnesium oxide, and citric acid; PEG: Polyethylene glycol; ADR: Adverse drug reaction; AE: Adverse event; PEG: Polyethylene glycol; SPMC: Sodium picosulfate, magnesium oxide, and citric acid; TEAE: Treatment-emergent adverse event.