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 |
|---|---|---|---|---|---|---|---|---|
| PP-based Health Behavior Intervention | Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence. | 0 | None | 1 | 15 | 3 | 15 | View |
| MI-based Educational Control Condition | Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. MI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management. | 0 | None | 1 | 15 | 5 | 15 | View |
| Treatment as Usual (TAU) | Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits. | 0 | None | 1 | 15 | 1 | 15 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Unexpected Fall | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Unexpected Shortness of Breath and Weight Gain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Unexpected Chest Pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Unexpected Shortness of Breath | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Unexpected Arm Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fractured foot and ankle | SYSTEMATIC_ASSESSMENT | General disorders | None | View |