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 |
|---|---|---|---|---|---|---|---|---|
| bvFTD: Anodal tDCS of the SN | bvFTD: anodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks. Stimulation target: prefrontal cortex | 0 | None | 0 | 12 | 5 | 12 | View |
| AD: Anodal tDCS of the DMN | AD: anodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks. Stimulation target: inferior parietal cortex | 0 | None | 0 | 11 | 5 | 11 | View |
| AD: Cathodal tDCS of the SN | AD: cathodal tDCS of the salience network (SN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks. Stimulation target: prefrontal cortex | 0 | None | 0 | 11 | 6 | 11 | View |
| bvFTD: Cathodal tDCS of the DMN | bvFTD: cathodal tDCS of the default mode network (DMN) with transcranial direct current stimulation (tDCS): 10 daily 25-minutes tDCS sessions over two weeks. Stimulation target: inferior parietal cortex | 0 | None | 1 | 11 | 5 | 11 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Intestinal infarct | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Itching (tDCS related discomfort sensation) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pain (tDCS related discomfort sensation) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Warmth/Heat (tDCS related discomfort sensation) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Other tDCS related discomfort sensations | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Burning (tDCS related discomfort sensation) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pinching (tDCS related discomfort sensation) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Metallic/Iron taste (tDCS related discomfort sensation) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Fatigue (tDCS related discomfort sensations) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |