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 |
|---|---|---|---|---|---|---|---|---|
| Advair and Advair Diskuses, Then Advair and Flovent Diskuses | On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5. On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5. | None | None | 0 | 6 | 0 | 6 | View |
| Advair and Flovent Diskuses, Then Advair and Advair Diskuses | On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5. On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5. | None | None | 0 | 4 | 0 | 4 | View |