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 @ 5:04 PM
Ignite Modification Date:
2025-12-25 @ 2:43 PM
NCT ID:
NCT05104450
Description:
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
Frequency Threshold:
0
Time Frame:
We systematically collected adverse events (AE) by body system as part of the the 12- and 21-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition. We also systematically reviewed the electronic health record for discharge summaries among all participants at 12 months, and at 21 month follow-up among those who did not complete follow-up surveys.
Study:
NCT05104450
Study Brief:
Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lifestyle Intervention | The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care. The lifestyle behavior change intervention is aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period. | 1 | None | 54 | 348 | 126 | 348 | View |
| Usual Care Control | Participants in this arm will continue with usual care without the lifestyle intervention. | 2 | None | 40 | 348 | 127 | 348 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematological | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Cardiovascular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hepatobiliary | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Metabolic | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Psychological | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pulmonary/Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dermatological | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Renal/Urologic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematological | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Cardiovascular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Psychological | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hepatobiliary | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Metabolic | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Renal/Urologic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Pulmonary/Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dermatological | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |