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 |
|---|---|---|---|---|---|---|---|---|
| Ibuprofen and Acetaminophen | Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Acetaminophen: Acetaminophen 500-1000mg every 6 hours Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) | 0 | None | 0 | 60 | 5 | 60 | View |
| Ibuprofen and Placebo | Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours | 0 | None | 0 | 60 | 2 | 60 | View |