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:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
NCT ID:
NCT02656693
Description:
Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Frequency Threshold:
5
Time Frame:
Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study.
Study:
NCT02656693
Study Brief:
Integrating Online Weight Management With Primary Care Support
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Usual Care | Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.) | 0 | None | 12 | 326 | 0 | 326 | View |
| Combined Intervention | Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol. | 1 | None | 18 | 298 | 0 | 298 | View |
| Online Program Only | Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. | 0 | None | 11 | 216 | 0 | 216 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coronary arteriogram | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronary artery bypass grafting (CABG) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Heart attack | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Endometrial cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Melanoma in situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Alcohol use disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Brain surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Spinal stenosis of lumbar region | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Transient ischemic attack | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| GI bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
Other Events(If Any):