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 |
|---|---|---|---|---|---|---|---|---|
| CD07805/47 Gel 0.5% | None | None | None | 12 | 449 | 101 | 449 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abscess tooth w/ secondary submandibular infection | None | Infections and infestations | None | View |
| Osteoarthritis of left hip | None | Musculoskeletal and connective tissue disorders | None | View |
| Advanced squamous cell carcinoma of the lung | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| COPD | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Encephalopathy | None | Nervous system disorders | None | View |
| Invasive ductal carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Distal Esophageal Schatzki's Ring | None | Gastrointestinal disorders | None | View |
| Unstable Angina | None | Cardiac disorders | None | View |
| Right Ovarian Cyst | None | Reproductive system and breast disorders | None | View |
| Sustained Ventricular Tachycardia | None | Cardiac disorders | None | View |
| Atypical Pneumonia | None | Infections and infestations | None | View |
| Sepsis | None | Infections and infestations | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Synovitis Right Ankle | None | Musculoskeletal and connective tissue disorders | None | View |
| Persistent Abnormal Uterine Bleeding | None | Reproductive system and breast disorders | None | View |
| Bilateral Achilles Tendon ruptures | None | Injury, poisoning and procedural complications | None | View |