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 |
|---|---|---|---|---|---|---|---|---|
| Social Cognition | Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states. | None | None | 0 | 19 | 0 | 19 | View |
| Cognitive Remediation | Cognitive remediation: Computer exercises in attention, memory, and speed of processing. | None | None | 1 | 24 | 0 | 24 | View |
| Hybrid Group | Half of the sessions were cognitive remediation and half were social cognitive training. | None | None | 2 | 21 | 1 | 21 | View |
| Control - Social Skills Training | This group was a control for the amount of time in sessions. There was no social cognitive training. | None | None | 3 | 21 | 0 | 21 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| MRSA cellulitis in both hands. | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| 5150 hold for suicidal thinking, aggressive behavior and exessive use of alcohol | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| 5150 hold for relapse using cocaine and alcohol | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| 5150 for threatening to sexually assault a female Veteran | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Subject was hospitalized for 8 days due to an inflammed pancreas. | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| 5150 hold for aggressive argument with his mother. | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ER visit for public intoxication. | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |