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 |
|---|---|---|---|---|---|---|---|---|
| 2 Supportive-expressive Psychotherapy | Participants will receive supportive-expressive psychotherapy. Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship. | None | None | 0 | 51 | 1 | 51 | View |
| 3 Pill Placebo | Participants receive placebo. Pill Placebo : Participants will receive a pill placebo. | None | None | 0 | 50 | 0 | 50 | View |
| 1 Sertraline | Participants receive sertraline. Sertraline : Participants will receive sertraline. | None | None | 0 | 55 | 0 | 55 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| passive suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |