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 |
|---|---|---|---|---|---|---|---|---|
| Chronic Renal Disease (CKD3b) | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 30-45 Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements | 0 | None | 0 | 0 | 0 | 0 | View |
| Control | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of greater than 60 Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements | 0 | None | 0 | 0 | 0 | 0 | View |
| Chronic Renal Disease (CKD4) | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of 15-30 Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements | 0 | None | 0 | 0 | 0 | 0 | View |
| Chronic Renal Disease (CKD5) | heparin at 50unit/kg of body weight having glomerular filtration rate (GFR) of less than 15, or on hemodialysis Heparin: This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements | 0 | None | 0 | 0 | 0 | 0 | View |