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 |
|---|---|---|---|---|---|---|---|---|
| tx 1: Acetaminophen and Education | Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week. Patient and family received standard education on concussion management in the Emergency department. Acetaminophen: routine administration of medication for a 72 hour period | None | None | 0 | 0 | 0 | 0 | View |
| Tx 2: Ibuprofen and Education | Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week. Patient and family received standard education on concussion management in the Emergency department. Ibuprofen: routine administration of medication for a 72 hour period | None | None | 0 | 0 | 0 | 0 | View |
| Tx 3: Ibuprofen/Acetaminophen/Education | Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week. Patient and family received standard education on concussion management in the Emergency Department. Acetaminophen: routine administration of medication for a 72 hour period Ibuprofen: routine administration of medication for a 72 hour period | None | None | 0 | 0 | 0 | 0 | View |
| Tx 4: no Routine Meds and Education | Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen. The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period. | None | None | 0 | 0 | 0 | 0 | View |