Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Active Comparator: High-Flow Nasal Cannula Oxygen Therapy | Children in the high-flow group received heated and humidified high-flow oxygen at a rate of 2 L\*kg/min (maximum 25 L/min), using an age-appropriate Optiflow Junior cannula and Airvo 2 high-flow system (Fisher and Paykel Healthcare). The initial fraction of inspired oxygen (FiO2) was set at 40%. The starting flow rate continued for a minimum of 4 hours. According to the patients' clinical response, the flow rate was decreased by 0.5 L\*kg/min per hour. The FiO2 was adjusted to obtain the oxygen saturation levels between 92-98%. When the flow rate was at 0.5 L\*kg/min, and the FiO2 was equal to the ambient oxygen concentration, High-Flow nasal cannula oxygen therapy was stopped. | 0 | None | 0 | 39 | 5 | 39 | View |
| Active Comparator: Standard Face Mask Oxygen Therapy | Children in the standard-therapy group received supplemental oxygen via a simple face mask, a range of 6-10 L/min, to maintain the oxygen saturation level between 92-98%. Those who sustained the oxygen saturation \>92% in the ambient oxygen concentration were weaned off Standard Face Mask Oxygen Therapy. | 0 | None | 0 | 48 | 1 | 48 | View |