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 |
|---|---|---|---|---|---|---|---|---|
| BioFoam Surgical Matrix | Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery | None | None | 0 | 0 | 0 | 0 | View |
| Gelfoam Plus | Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery | None | None | 1 | 1 | 1 | 1 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Recurrence of Hepatocellular Carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Hernia | None | Gastrointestinal disorders | None | View |
| Elevated Total Protein | None | Surgical and medical procedures | None | View |
| High Fibrinogen | None | Surgical and medical procedures | None | View |
| High WBC | None | Surgical and medical procedures | None | View |
| Liver Function Tests Elevated ALT & AST | None | Surgical and medical procedures | None | View |
| Low Cholesterol | None | Surgical and medical procedures | None | View |
| Low Lipase | None | Surgical and medical procedures | None | View |
| Low Sodium | None | Surgical and medical procedures | None | View |
| Pleural Effusion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Upper Respiratory Infection | None | Infections and infestations | None | View |
| Abnormal Monocyte Count | None | Surgical and medical procedures | None | View |
| Elevated AST | None | Surgical and medical procedures | None | View |
| Hepatic Nodules | None | Hepatobiliary disorders | None | View |
| High ALT | None | Surgical and medical procedures | None | View |
| High GGTP | None | Surgical and medical procedures | None | View |
| High LDH | None | Surgical and medical procedures | None | View |
| Incisional Pain | None | Surgical and medical procedures | None | View |
| Intermittent Changes in Neutrophil Count (High) | None | Surgical and medical procedures | None | View |
| Low Bilirubin, Total | None | Surgical and medical procedures | None | View |
| Low Calcium | None | Surgical and medical procedures | None | View |
| Low Creatinine | None | Surgical and medical procedures | None | View |
| Low HGB | None | Surgical and medical procedures | None | View |
| Low Pancreatic Amylase | None | Surgical and medical procedures | None | View |
| Low Phosphorus | None | Surgical and medical procedures | None | View |
| Low WBC | None | Surgical and medical procedures | None | View |
| Lower Extremity Edema | None | General disorders | None | View |
| Sinusitis | None | Infections and infestations | None | View |
| Tachycardia | None | Cardiac disorders | None | View |
| Worsened Baseline Low HCT | None | Surgical and medical procedures | None | View |
| Worsened Baseline Low RBC | None | Surgical and medical procedures | None | View |