Table 4: Adverse events and use of concomitant medications in test and control groups

From: A synbiotic-containing amino-acid-based formula improves gut microbiota in non-IgE-mediated allergic infants

 Test (N=35)Control (N=36)P value (Fisher’s exact test)
Adverse events, N (%)   
  Any adverse event20 (57.1%)23 (65.7%)0.624
  Mild15 (42.9%)15 (42.9%) 
  Moderate4 (11.4%)7 (20.0%) 
  Severea1 (2.9%)1 (2.9%) 
 Preferred term descriptionb   
  Gastrointestinal disorders11 (31.4%)13 (37.1%)0.802
  Infections and infestations10 (28.6%)12 (34.3%)0.797
Concomitant medication, N (%)   
  Any concomitant medication21 (60.0%)28 (80.0%)0.117
  Anti-infectives for systemic use3 (8.6%)12 (34.4%)0.018
  1. aReported severe adverse events were feeding disorder of infancy or early childhood (test group) and bronchiolitis and feeding disorder of infancy or early childhood (control group).
  2. bThe two most frequently reported preferred terms of adverse event are shown.
  3. cOnly categories (of total nine categories) with a statistically significant difference (P<0.05) are shown.