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
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
NCT ID:
NCT02714257
Description:
Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
Frequency Threshold:
0.5
Time Frame:
Data were collected every 4 months for the full 36-month duration of study participation.
Study:
NCT02714257
Study Brief:
Working to Increase Stability Through Exercise
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Enhanced Usual Care - Control Group | Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure. | 22 | None | 162 | 569 | 0 | 569 | View |
| Enhanced Usual Care Plus Exercise Coaching Intervention | Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation. | 30 | None | 79 | 570 | 0 | 570 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Elective Joint Replacement | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Other Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Atrial Fibrillation/Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Acute Coronary Syndrome / Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Stroke / Transient Ischemic Attack / Intracranial Hemorrhage | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fluid / Electrolyte Abnormality | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Imbalance (syncope, dizziness, vertigo) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):