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 |
|---|---|---|---|---|---|---|---|---|
| Exercising in Filtered Air Following Placebo Inhalation | Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication. Placebo medication: Inhaling placebo medication Filtered Air: Breathing filtered air Exercise: Cycling at 60% of VO2max on a cycle ergometer | 0 | None | 0 | 18 | 0 | 18 | View |
| Exercising in Ozone Following Salbutamol Inhalation | Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol. Salbutamol: Inhaling 200ug of salbutamol Ozone: Breathing 170ppb ozone Exercise: Cycling at 60% of VO2max on a cycle ergometer | 0 | None | 0 | 18 | 0 | 18 | View |
| Exercising in Filtered Air Following Salbutamol Inhalation | Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol. Salbutamol: Inhaling 200ug of salbutamol Filtered Air: Breathing filtered air Exercise: Cycling at 60% of VO2max on a cycle ergometer | 0 | None | 0 | 18 | 0 | 18 | View |
| Exercising in Ozone Following Placebo Inhalation | Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication. Placebo medication: Inhaling placebo medication Ozone: Breathing 170ppb ozone Exercise: Cycling at 60% of VO2max on a cycle ergometer | 0 | None | 0 | 18 | 0 | 18 | View |