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 |
|---|---|---|---|---|---|---|---|---|
| Diclofenac 35 mg Two Times Daily | Diclofenac Test (two times daily): Capsules | None | None | 3 | 104 | 11 | 104 | View |
| Diclofenac 35 mg Three Times Daily | Diclofenac Test (three times daily): Capsules | None | None | 4 | 98 | 21 | 98 | View |
| Placebo | Placebo: Capsule | None | None | 2 | 103 | 13 | 103 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | None | Investigations | None | View |
| Appendicitis | None | Infections and infestations | None | View |
| Aspartate aminotransferase increased | None | Investigations | None | View |
| Chronic obstructive pulmonary disease | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Deep vein thrombosis | None | Vascular disorders | None | View |
| Hepatic cancer metastatic | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Metastases to lung | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Non-cardiac chest pain | None | General disorders | None | View |
| Pulmonary embolism | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Syncope | None | Nervous system disorders | None | View |
| Malignant melanoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Metastatic neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Hemiplegic migraine | None | Nervous system disorders | None | View |