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 |
|---|---|---|---|---|---|---|---|---|
| Placebo Comparator: Placebo | Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. Methamphetamine: In each arm, subjects will receive doses of methamphetamine. Methylphenidate: In each arm, subjects will receive methylphenidate capsules. Placebo oral capsule: In each arm, subjects will receive placebo capsules. | 0 | None | 0 | 3 | 2 | 3 | View |
| Active Comparator: Duloxetine (60 mg) | Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance. Methamphetamine: In each arm, subjects will receive doses of methamphetamine. Methylphenidate: In each arm, subjects will receive methylphenidate capsules. Placebo oral capsule: In each arm, subjects will receive placebo capsules. Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm. | 0 | None | 0 | 4 | 2 | 4 | View |