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 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
NCT ID:
NCT02172820
Description:
Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Frequency Threshold:
0
Time Frame:
1 year
Study:
NCT02172820
Study Brief:
Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Financial Incentives | Participants receive financial incentives for completing exercise sessions. Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions. 39% fewer hospital contacts in the incentive condition (p=0.079) | 1 | None | 26 | 65 | 25 | 65 | View |
| Control | Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits. | 2 | None | 27 | 65 | 30 | 65 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Hospitalizations | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |