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 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
NCT ID:
NCT04075994
Description:
The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
Frequency Threshold:
0
Time Frame:
Data collection occurred from date of consent through the participants 12-month visit.
Study:
NCT04075994
Study Brief:
Atrial Fibrillation Health Literacy and Information Technology Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intervention | Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days. | 2 | None | 30 | 123 | 18 | 123 | View |
| Usual Care | Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days. | 2 | None | 26 | 120 | 26 | 120 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Heart failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Chest pain-cardiac | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Aortic valve disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Atrial flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Atrioventricular block first degree | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Coronary Artery Disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Pericarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Sinus bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Death NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Ambulatory dysfunction | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| COPD exacerbation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Stridor | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Tracheal stenosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Colonic hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Acute upper GI bleed | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Hematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Rectal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Intracranial hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Transient ischemic attacks | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Movements involuntary | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Diabetic ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Gun shot wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Intracranial hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hematruia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Suprapubic catheter dislodged | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Renal calculi | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| INR increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Medication side effect | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (5.0) | View |
| Non-small cell lung cancer resection | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (5.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest pain-cardiac | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Atrial flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Elevated blood pressure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Bruising | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Bleeding varicose vein | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Chest wall pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Impaired mobility | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Mucositis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Rectal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Flu like symptoms | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Right leg pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Shortness of breath | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Peripheral motor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Transient ischemic attacks | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Bronchial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Joint infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Floaters | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Skin lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Viral syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |