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 |
|---|---|---|---|---|---|---|---|---|
| All Participants Included in the Safety Evaluation | Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin | None | None | 17 | 4033 | 0 | 4033 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| ANGINA UNSTABLE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| ATRIAL FLUTTER | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| CORONARY ARTERY OCCLUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| OESOPHAGEAL VARICES HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| BILE DUCT STONE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| CHRONIC HEPATITIS C | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| HYPERLIPIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| THYROID NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| TENSION HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| KNEE ARTHROPLASTY | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |