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 |
|---|---|---|---|---|---|---|---|---|
| Adverse Event | Adverse Event (AE) refers to any harmful medical event that occurs during a clinical trial, regardless of whether it is causally related to the investigational drug. Adverse events include the following situations: Adverse Reaction (AR) related to the investigational drug: refers to any harmful medical event caused by the pharmacological effects or other reasons of the investigational drug under normal usage conditions. Adverse events unrelated to the investigational drug: Refers to any harmful medical event that occurs during a clinical trial, but is scientifically determined to have no causal relationship with the investigational drug. Serious Adverse Event (SAE): refers to any harmful medical event that occurs during a clinical trial, regardless of whether it is causally related to the investigational drug, resulting in one of the following consequences: Causing death; Endangering life (i.e., if not intervened in a timely manner, it may lead to death); Need for hospitalization or extended hospitalization; Causing persistent or significant disability or functional impairment; Causing congenital malformations or birth defects; Significant medical interventions (such as surgery, blood transfusions, etc.) are required. | 1 | None | 31 | 149 | 3 | 149 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Subcutaneous tunnel infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Displacement of peritoneal dialysis catheter | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Diabetic foot infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Respiratory system infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Gastrointestinal lesions and fatigue | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |