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 |
|---|---|---|---|---|---|---|---|---|
| SCI MoviPrep® (With NG) | (SCI, GFR\<=50ml/min and GFR \>=50ml/min) MoviPrep (with NG) Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established | None | None | 0 | 13 | 7 | 13 | View |
| SCI PIEE (With NG) | (SCI, GFR\>=50ml/min) PIEE (with NG) Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established | None | None | 0 | 12 | 10 | 12 | View |
| Control MoviPrep® Only | (Control, GFR\>=50ml/min) MoviPrep® only (no NG) | None | None | 1 | 28 | 4 | 28 | View |
| SCI MoviPrep® (Without NG) | (SCI, GFR\<=50ml/min and GFR \>=50ml/min) MoviPrep (without NG) | None | None | 0 | 14 | 1 | 14 | View |
| SCI PIEE (Without NG) | (SCI, GFR\>=50ml/min) PIEE ( without NG) | None | None | 0 | 12 | 4 | 12 | View |
| SCI PIEE Only | (Control, GFR\>=50ml/min) PIEE only (no NG) | None | None | 1 | 27 | 20 | 27 | View |