Adverse Events Module

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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 @ 3:19 AM
Ignite Modification Date: 2025-12-26 @ 1:57 AM
NCT ID: NCT02941705
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected over 1 year following infusion.
Study: NCT02941705
Study Brief: Regression of Fibrosis & Reversal of Diastolic Dysfunction in HFpEF Patients Treated With Allogeneic CDCs
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RECIEVED CELLS this arm will receive the CDCs /CAP 1002 solution Allogeneic Derived Cells: patients will have the CAP-1002 solution delivered through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics. 1 None 3 13 12 13 View
CONTROL ARM this arm will receive a solution during randomization but will not receive the CDCs Placebo/Control Arm: patients will receive the placebo through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics. 0 None 3 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ischemic Stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vertigo/sinus infection NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chronotropic incompetence/ pacemaker implanted NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute HFpEF exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pancreatic adenocarcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute HFpEF Exac NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
AKI NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anxiety during RHC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back Pain with Spinal Nerve Ablation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Confusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated Bilirubin NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated BNP NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated Troponin NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Emesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypervolemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increased Swelling NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ischemic Stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypervolemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Laryngeal papillomas excision NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Memory Loss NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nonflow Limiting Staining in Prox LCx NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pancreatic Adenocarcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Potential Metabolic Acidosis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Right Knee Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shortness of Breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin tear from blood pressure cuff NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Supraventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncopal Episode NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tachy Arrythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombophebitis of Right Arm NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Transaminitis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Transient AV Block during RCA infusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
UTI NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vertigo/Chronic Sinus Infection NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View