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 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 2:15 PM
NCT ID:
NCT00768066
Description:
Adverse events are described by MedDRA preferred term.
Frequency Threshold:
5
Time Frame:
30-days after transendocardial stem cell injection
Study:
NCT00768066
Study Brief:
The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. | None | None | 2 | 19 | 6 | 19 | View |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. | None | None | 2 | 19 | 7 | 19 | View |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. | None | None | 3 | 21 | 5 | 21 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina Pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Atrioventricular block complete | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Intracardiac thrombus | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Device electrical finding | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Device malfunction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Fibrosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Acute respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Dyspnoea exertional | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Percutaneous coronary intervention | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Intracardiac thrombus | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Vertigo positional | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 10.0 | View |
| Eye inflammation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Food Poisoning | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Chest Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Atypical pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Investigations | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Injury, Poisoning and procedural complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.0 | View |
| Metabolism and nutrition disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.0 | View |
| Musculoskeletal and connective tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| Nervous system disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Renal failure chronic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.0 | View |
| Epididymitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 10.0 | View |
| Skin and subcutaneous tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |
| Surgical and Medical procedures | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Blood and lymphatic system disorders | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.0 | View |
| Respiratory, thoracic and mediastinal disorders | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |