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 |
|---|---|---|---|---|---|---|---|---|
| ROP/KET/CLON/EPI/SAL | Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml | 0 | None | 0 | 34 | 0 | 34 | View |
| Placebo | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml | 0 | None | 0 | 30 | 0 | 30 | View |