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 |
|---|---|---|---|---|---|---|---|---|
| ARV Naive | ARV naive (have never been on antiretrovirals before) | None | None | 2 | 18 | 12 | 18 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Incisional Hematoma (Grade 1) | None | Skin and subcutaneous tissue disorders | None | View |
| Low glucose 34 (Grade 3) | None | Metabolism and nutrition disorders | None | View |
| Low glucose 48 (Grade 2) | None | Metabolism and nutrition disorders | None | View |
| Tachycardia (Grade 2) | None | Cardiac disorders | None | View |
| Bone Mineral Density (BMD)/T scores -2.3 and -3.2 | None | Musculoskeletal and connective tissue disorders | None | View |
| Elevated creatine kinase (CK) levels (Grades 3 and 4) | None | Musculoskeletal and connective tissue disorders | None | View |
| Elevated alanine aminotransferase (ALT) 207 (Grade 2) | None | Hepatobiliary disorders | None | View |
| Elevated low-density lipoprotein (LDL) 175 (Grade 2) | None | Metabolism and nutrition disorders | None | View |
| Low absolute neutrophil count (ANC) (Grades 2 and 3) | None | Blood and lymphatic system disorders | None | View |
| Low white blood cell (WBC) count (Grade 2) | None | Blood and lymphatic system disorders | None | View |
| Incisional Seroma | None | Skin and subcutaneous tissue disorders | None | View |
| Infected Incisional Hematoma (Grade 2) | None | Skin and subcutaneous tissue disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Elevated Aspartate aminotransferase (AST) (Grades 2 and 3) | None | Hepatobiliary disorders | None | View |
| Elevated Cholesterol 257 (Grade 2) | None | Metabolism and nutrition disorders | None | View |