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 |
|---|---|---|---|---|---|---|---|---|
| NHF With or Without Oxygen | NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge NHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. | 0 | None | 0 | 29 | 10 | 29 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Oral thrush | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| AECOPD | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| General unwellness/tired | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |