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 |
|---|---|---|---|---|---|---|---|---|
| Montelukast 10 mg/Day | Subjects will receive two 5mg tablets of Montelukast/day. Montelukast: Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast. | None | None | 0 | 0 | 0 | 0 | View |
| Montelukast 5mg/Day | Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day. 5 mg Montelukast: Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day. | None | None | 0 | 0 | 0 | 0 | View |
| Placebo | Subjects will receive two placebo tablets per day. placebo: Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day. | None | None | 0 | 0 | 0 | 0 | View |
| Subjects Who Were Not Unblinded so Arm is Unknown | Subjects were never unblinded and no results were reported due to small number of enrolled subjects and lack of amount of data to show any demonstrable differences. | None | None | 0 | 4 | 0 | 4 | View |