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Table 4 Adverse events

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

 Patients, n/N (%) 
OAPPlaceboP value
Adverse events related to study medication
 Self-reported side effects during intervention perioda
  No side effects13/27 (48.1)11/29 (37.9)0.596
 Gastro-intestinal side effects
  Diarrhea14/27 (51.9)6/29 (20.7)0.015
  Nausea3/27 (11.1)0/290.065
  Stomach ache7/27 (25.9)6/29 (20.7)0.624
  Loss of appetite1/27 (3.7)0/290.296
  Flatulence1/27 (3.7)3/29 (10.3)0.335
  Other side effects5/27 (18.5)4/290.630
  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 procedures0/39 (0.0)0/39 (0.0)0
Serious adverse event (SAE)1/39 (2.6)0/39 (0.0)1.000
  1. 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
  2. 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