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 |
|---|---|---|---|---|---|---|---|---|
| Imagined Gait Intervention | During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. | 0 | None | 0 | 25 | 5 | 25 | View |
| Visual Imagery Intervention | During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. | 0 | None | 1 | 24 | 11 | 24 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back/shoulder pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain in lower extremities | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain in upper extremities | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Enlarged prostate | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |