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 |
|---|---|---|---|---|---|---|---|---|
| Naltrexone and Placebo | Nal Naltrexone: 150 mg daily for males; 100 mg daily for females | None | None | 6 | 40 | 10 | 40 | View |
| Modafinil and Placebo | Mod Modafinil: 400 mg daily | None | None | 6 | 37 | 8 | 37 | View |
| Double Placebo | Placebo Placebo: 400 mg and/or 100-150 mg placebo pills | None | None | 11 | 42 | 4 | 42 | View |
| ModNal | Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily | None | None | 11 | 45 | 11 | 45 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Exacerbation of cocaine and alcohol | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Depression or Hallucinations | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Arrested for Homicide | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (10.0) | View |