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 |
|---|---|---|---|---|---|---|---|---|
| Group 1- Received Ibuprofen (N=39) | Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose); Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary | 0 | None | 0 | 39 | 0 | 39 | View |
| Group 2- Received Dexamethasone (N=43) | Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. | 0 | None | 0 | 43 | 0 | 43 | View |
| Group 3 - Received Placebo (N=35) | Placebo: This group receives 1 hour before surgery placebo. Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. | 0 | None | 0 | 35 | 0 | 35 | View |