Table 6 Adverse events classified by the observers to have a possible, probable or confirmed causal relationship to the consumption of ESPRICO® (MedDRA System Organ Classes and Preferred Terms).
N | % | |
|---|---|---|
Infections and parasitic diseases | 1 | 0.1 |
Infection | 1 | 0.1 |
Psychiatric diseases | 5 | 0.6 |
Difficulty sleeping through the night | 1 | 0.1 |
Restlessness | 1 | 0.1 |
Sleep-related problems | 2 | 0.2 |
Behavioural disorder | 1 | 0.1 |
Diseases of the gastrointestinal tract | 8 | 1.0 |
Abdominal symptoms | 1 | 0.1 |
Distended abdomen | 1 | 0.1 |
Abdominal pain | 2 | 0.2 |
Dyspepsia | 1 | 0.1 |
Nausea | 1 | 0.1 |
Vomiting | 2 | 0.2 |
Diseases of the skin and hypodermis | 1 | 0.1 |
Urticaria | 1 | 0.1 |
Injury, intoxication and complications resulting from interventional procedures | 1 | 0.1 |
Nausea in connection with a procedure | 1 | 0.1 |
Children with no adverse reactions | 796 | 98.3 |
Children, total | 810 | 100 |