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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT04355728
Description:
None
Frequency Threshold:
0
Time Frame:
3 months
Study:
NCT04355728
Study Brief:
Use of UC-MSCs for COVID-19 Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| UC-MSCs Group | Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment. | 3 | None | 5 | 12 | 8 | 12 | View |
| Control Group | Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol. | 7 | None | 8 | 12 | 10 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| GI Bleeding 2ry to Clostridium Difficile Infection | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 5.0 | View |
| Colon Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 5.0 | View |
| Cardiact Arrest-Death due to Difficult Intubation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 5.0 | View |
| Acute respiratory Failure 2ry to COVID-Death | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 5.0 | View |
| Death-Acute Hypoxemic Respiratory Failure Secondary to COVID-19 Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE Version 5.0 | View |
| Cardiac Arrest/Pulseless Electrical Activity Cardiac Arrest/Cardiac Arrest Secondary to Acute Respir | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 5.0 | View |
| Traumatic Tension Pneumotorax post-CPR | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Severe Respiratory Acidosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| [DEATH] Multisystem Organ Failure (Death)/Multiple Organ Dysfunction Syndrome-Death | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE Version 5.0 | View |
| [DEATH] Cardiac Arrest-Death/Cardiopulmonary Arrest-Death/Asystole -Death | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 5.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE Version 5.0 | View |
| Severe Metabolic Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE Version 5.0 | View |
| Septic Shock-Hospital acquired Pseudomona Aeruginosa bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE Version 5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 5.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 5.0 | View |
| Exacerbation of COVID ARDS-Septic Shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE Version 5.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 5.0 | View |
| Tachycardia after infusion of Investigational Product | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 5.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE Version 5.0 | View |
| Clostridium Difficile Infection | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 5.0 | View |
| Mild Gastrointestinal Bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 5.0 | View |
| Transaminitis/Transaminitis-Liver Shock | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE Version 5.0 | View |
| Increased ALT, AST, and Alkaline Phosphatase | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE Version 5.0 | View |
| Increased Direct Bilirubin | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE Version 5.0 | View |
| Abnormal Urinalysis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE Version 5.0 | View |
| Candiduria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE Version 5.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE Version 5.0 | View |
| Leukocytosis/Leukocytosis (Increased WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE Version 5.0 | View |
| Severe Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE Version 5.0 | View |
| Thrombocytopenia/Heparin-induced Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE Version 5.0 | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE Version 5.0 | View |
| Bilateral Common Femoral Vein DVT | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE Version 5.0 | View |
| Candida Albicans Fungemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE Version 5.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE Version 5.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE Version 5.0 | View |
| Mild Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE Version 5.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE Version 5.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE Version 5.0 | View |
| MRSA Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE Version 5.0 | View |
| Paenebacillus Pabuli Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE Version 5.0 | View |
| Positive Blood Culture Streptococcus Mitis and Streptococcus Oralis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE Version 5.0 | View |
| Staphylococcus haemolyticus bacteremia and Candida orthopsilosi Fungemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE Version 5.0 | View |
| Staphylococcus Hominis Bacteremia/Staphylococcus Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE Version 5.0 | View |
| Left Calf Collection | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE Version 5.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 5.0 | View |
| Dysconjugated gaze | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 5.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE Version 5.0 | View |
| Acute Kidney Injury/Oliguric Acute Kidney Injury/ Anuric Acute Kidney Injury/Acute Kidney Injury (AK | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE Version 5.0 | View |
| Pneumoperitoneum | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Aspiration Pneumonitis, suspected | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Bradypnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Enterococcus Faecalis, Klebsiella Pneumoniae, Candida Auris/Duobushaemulonis in bronchial aspirate | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Enterococcus Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| MRSA Hospital Acquired Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Pneumomediastinum | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Respiratory Failure - Intubation/Hypoxemic respiratory failure requiring intubation and mechanical v | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Subcutaneous Emphysema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Ventilator Acquired Pneumonia (VAP) with Pseudomona aureginosa | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |
| Worsening of Hypoxemia/Deterioration of Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | View |