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: 2025-12-24 @ 7:13 PM
Ignite Modification Date: 2025-12-25 @ 4:48 PM
NCT ID: NCT00203203
Description: None
Frequency Threshold: 1
Time Frame: Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Study: NCT00203203
Study Brief: Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control, Then Stem Cell Therapy Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. None None 7 10 9 10 View
Stem Cell Therapy Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. None None 11 20 18 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain and slightly elevated Troponin I NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Confusion/disorientation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Elevated troponin,chestpain and fever with episode of cellulitis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
False positive culture on processed stem cells at day 5 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalized for chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalized for heart failure at one year NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Placement of AICD NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary edema & slightly elevated Troponin I with ablation of atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary edema within 24 hrs of treatment NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Replacement of AICD NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Restenosis without symptoms at 6 months, received stent NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Staph aureus septicemia (left sternoclavicular area) leg NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Troponin I elevation in presence of new onset Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
bronchitis, decompensated heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
decompensated heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
elevated Troponin T in presence of bacteremia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
supraventricular tachycardia ablation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
unstable angina and stent NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
urosepsis and chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ventricular tachycardia during 6 month F/Ucath requiring cardioversion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
edema, upper extremities NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
electrocardiogram changes NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
eyes sensitive to light NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
fall/ balance problems NON_SYSTEMATIC_ASSESSMENT General disorders None View
fatigue/ weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View
fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
gastroespohageal reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gout, increased symptoms NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
gum bleeding NON_SYSTEMATIC_ASSESSMENT General disorders None View
headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
heart palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hematoma at catheter site NON_SYSTEMATIC_ASSESSMENT General disorders None View
hyperglycermia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hypoglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
influenza/ flu-like symptoms NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
insomnia/ sleep disorders NON_SYSTEMATIC_ASSESSMENT General disorders None View
itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
lesion right foot NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
muscle pain/pull NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
myocardial infaction, non-ST elevation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
numbness/ tingling in extremities NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
petechia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pleuritic chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
probable obstructive sleep apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pulmonary edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
renal insufficiency/ urinary problems NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
sciatica NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
scrotal edema/ erythema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
shingles NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
shortness of breath, lying down NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
shortness of breath/ increased shortness of breath/ difficulty breathing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
shoulder pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
sinus congestion/ compliant NON_SYSTEMATIC_ASSESSMENT General disorders None View
skin flushing NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
slurred speech/ dysphasia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
soreness/ brusing NON_SYSTEMATIC_ASSESSMENT General disorders None View
spider bite NON_SYSTEMATIC_ASSESSMENT General disorders None View
swelling/ edema lower extremities NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
swelling/ edema upper extremity NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
tremors NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
urinary/ bladder problems NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
virus NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
weight gain NON_SYSTEMATIC_ASSESSMENT General disorders None View
white blood count, elevated NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
chronic obtructive pulmonary disease, increased symptoms NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cold/ congestion NON_SYSTEMATIC_ASSESSMENT General disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
crackles/ wheezes in lungs NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cramping NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
decrease in platelets/ hematocrit NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
diabetes uncontrolled NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
diaphoresis NON_SYSTEMATIC_ASSESSMENT General disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
digestive problems NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
disorientation NON_SYSTEMATIC_ASSESSMENT General disorders None View
dizziness/ light-headedness NON_SYSTEMATIC_ASSESSMENT General disorders None View
edema, extremity not specified NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
back/ hip pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
bloody nose NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
bone fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
bone pain, extremities NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
carbuncles on body NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
carpel tunnel release NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
changes in cardiac enzymes (CK-MB,BNP,CRP, troponin) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
changes in heart rate NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
changes in renal enzymes (BUN, creatinine, chloride) NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
chest pain/ increased chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
chills NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
ICD firing NON_SYSTEMATIC_ASSESSMENT General disorders None View
abcess left sternovascular joint NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
abcess tooth NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
abdominal bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abnormalities/ pain eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
abnormality on MRI scan NON_SYSTEMATIC_ASSESSMENT General disorders None View
albumin, increase NON_SYSTEMATIC_ASSESSMENT General disorders None View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View