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 |
|---|---|---|---|---|---|---|---|---|
| Levetiracetam 3000mg + Methadone | Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4. Levetiracetam: 3000mg orally everyday for 12 weeks | None | None | 0 | 16 | 1 | 16 | View |
| Levetiracetam 0mg + Methadone | Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13. Placebo: Placebo orally everyday for 13 weeks | None | None | 0 | 12 | 3 | 12 | View |