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Table 5 Number of serious adverse events occurring during the intervention period coded by MedDRA

From: Growth and safety evaluation of infant formulae containing oligosaccharides derived from bovine milk: a randomized, double-blind, noninferiority trial

Preferred term

Control n = 84

IF-BMOS n = 99

IF-BMOS + Pro n = 98

Breastfed n = 30

Pneumonia

3

2

1

1

Bronchitis

2

0

2

0

Apnoea

0

1

0

0

Dyspnoea

0

1

0

0

Upper respiratory tract infection

0

0

1

0

Abdominal pain

2

0

0

0

Gastroenteritis

2

0

0

0

Diarrhea

0

1

0

0

Gastroesophageal reflux

0

0

0

1

Stupor

1

0

0

0

Convulsions

0

0

1

0

Hernia inguinal

0

1

1

0

Sudden infant death syndrome

0

0

1

0

Urinary tract infection

0

0

1

0

Total

10

6

8

2

  1. MedDRA = Medical Dictionary for Regulatory Activities.