|
SAE preferred term**
|
L. reuteri (control)
(N = 68)
|
L. reuteri
+ GOS/FOS (experimental) (N = 72)
|
|---|
|
Total number of SAEs
|
7
|
14
|
|
Infection Viral
|
1
|
0
|
|
Influenza-Like Symptoms
|
1
|
0
|
|
Pneumonia (CXR/bacterial)
|
2
|
3
|
|
Vomiting
|
1
|
0
|
|
Varicella Zoster infection
|
1
|
0
|
|
Choking
|
1
|
0
|
|
Meningitis (aseptic)
|
0
|
1
|
|
Fever (>38.0 degrees Celsius)
|
0
|
4
|
|
Urinary Tract Infection (Bacterial)
|
0
|
1
|
|
Upper Respiratory Tract Infection
|
0
|
1
|
|
Rash Erythematous
|
0
|
1
|
|
Bronchitis
|
0
|
1
|
|
Apnoea Neonatal
|
0
|
1
|
|
Pharyngitis
|
0
|
1
|
- *Some infants had >1 SAE; **Coded according to World Health Organization Adverse Reactions Terminology.
