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 | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment. Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks. | None | None | 2 | 20 | 10 | 20 | View |
| Naltrexone and Dronabinol | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment. Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment. | None | None | 1 | 40 | 28 | 40 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea/vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Body Aches | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Mood changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Increased/decreased appetite | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| GI Distress | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Sweating/chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |