Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial

Table 4 Adverse events

	Patients, n/N (%)
	OAP	Placebo	P value
Adverse events related to study medication
Self-reported side effects during intervention period^a
No side effects	13/27 (48.1)	11/29 (37.9)	0.596
Gastro-intestinal side effects
Diarrhea	14/27 (51.9)	6/29 (20.7)	0.015
Nausea	3/27 (11.1)	0/29	0.065
Stomach ache	7/27 (25.9)	6/29 (20.7)	0.624
Loss of appetite	1/27 (3.7)	0/29	0.296
Flatulence	1/27 (3.7)	3/29 (10.3)	0.335
Other side effects	5/27 (18.5)	4/29	0.630
Serious adverse reaction (SAR)	0/39 (0.0)	0/39 (0.0)	0
Serious unexpected suspected adverse reaction (SUSAR)	0/39 (0.0)	0/39 (0.0)	0
Adverse events related to other study procedures	0/39 (0.0)	0/39 (0.0)	0
Serious adverse event (SAE)	1/39 (2.6)	0/39 (0.0)	1.000

Data are presented as n/N with data. Denominators for the self-reported side effects are based on the number of medication diaries that were returned: OAP 32/39 (82.1%), placebo 33/39 (84.6%). OAP, oral antibiotic prophylaxis
^aSelf-reported in medication diary during the three days of administration of study medication, including all participants who took at least one dose of study medication

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