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 |
|---|---|---|---|---|---|---|---|---|
| T-piece Nebulizer | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | 0 | None | 0 | 58 | 5 | 58 | View |
| Breath-Enhanced Nebulizer | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | 0 | None | 0 | 57 | 5 | 57 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Shakiness, Jitteriness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Weakness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |