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 |
|---|---|---|---|---|---|---|---|---|
| CRT+Skills Group | Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities | None | None | 2 | 25 | 6 | 25 | View |
| ICBCR + Skills Group | Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities | None | None | 1 | 24 | 7 | 24 | View |
| Skills Group + Generic Contact | Life skills group + up to five individual contacts with research staff without active cognitive training | None | None | 1 | 10 | 3 | 10 | View |