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 |
|---|---|---|---|---|---|---|---|---|
| Peptide T | Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months Peptide T | None | None | 8 | 106 | 75 | 106 | View |
| Placebo | Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months Placebo | None | None | 3 | 109 | 57 | 109 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death | None | Immune system disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Depression or Irritability | None | Psychiatric disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Nasal Congestion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Proteinuria | None | Renal and urinary disorders | None | View |
| Eosinophilia | None | Blood and lymphatic system disorders | None | View |