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 |
|---|---|---|---|---|---|---|---|---|
| Anxiety Management Education | Anxiety Management Education: written materials on management of anxiety for self-study | None | None | 0 | 19 | 9 | 19 | View |
| 10 Week Tai Chi Intervention | 10 week course in Evidence Based Tai Chi meeting 2 times per week 10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week | None | None | 1 | 28 | 9 | 28 | View |
| Enhanced Tai Chi Instruction | 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice | None | None | 1 | 28 | 12 | 28 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anger | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Anxiety with Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Cold | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Family Stress | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (Unspecified) | View |
| Feeling Blue | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Feeling sick | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Knee pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Poor sleep | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Stress | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Worry | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |