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 |
|---|---|---|---|---|---|---|---|---|
| Air Cleaner | A High Efficiency Particulate Air Cleaner (HEPA) intervention will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, including in-home health questionnaires, symptom-, diet-, and activity- diaries/recalls, blood, urine and exhaled breath testing, repeated measures of home hand-held lung function, and in-clinic pulmonary function testing with broncho-provocation. Participants will wear a light backpack with air monitoring devices during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which nasal and lower airway sampling will occur under conscious sedation. | 0 | None | 0 | 23 | 0 | 23 | View |
| Sham Air Cleaner | A sham air cleaner will be placed in the participant's home for one month. During the last week of the month, health assessments will be conducted, including in-home health questionnaires, symptom-, diet-, and activity- diaries/recalls, blood, urine and exhaled breath testing, repeated measures of home hand-held lung function, and in-clinic pulmonary function testing with broncho-provocation. Participants will wear a light backpack with air monitoring devices during the last week in order to measure their exposures to pollutants. Finally, at the end of the month, participants will be asked to report to the Johns Hopkins outpatient endoscopy suite for bronchoscopy, during which nasal and lower airway sampling will occur under conscious sedation. | 0 | None | 0 | 23 | 0 | 23 | View |