Table 6 Number of Serious Adverse Events (SAEs)* reported during the study, Intention-to-Treat
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 |