Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:17 PM
Ignite Modification Date: 2025-12-25 @ 8:55 PM
NCT ID: NCT02509156
Description: Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Frequency Threshold: 5
Time Frame: Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)
Study: NCT02509156
Study Brief: Stem Cell Injection in Cancer Survivors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Allo-MSCs Target dose of 100 million allo-MSCs Allo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure) 1 None 5 20 4 20 View
Placebo Buminate solution Placebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure) 0 None 11 17 4 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Chrohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Intestinal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Drug induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (19.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Post operative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Procedural pneumothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Lead dislodgement SYSTEMATIC_ASSESSMENT Product Issues MedDRA (19.0) View
Device lead damage SYSTEMATIC_ASSESSMENT Product Issues MedDRA (19.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (19.0) View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (19.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Cardiovascular deconditioning SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View