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 @ 1:17 PM
Ignite Modification Date:
2025-12-25 @ 12:25 PM
NCT ID:
NCT01681095
Description:
An assessment of medical records and case report forms were examined for AEs or SAEs. Reports were reviewed by the PI for accuracy and relation to study intervention.
Frequency Threshold:
5
Time Frame:
AEs were evaluated from time of consent to 4 days after surgery.
Study:
NCT01681095
Study Brief:
Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cardioplegia: Custodiol HTK Solution | Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20. Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C. | None | None | 3 | 55 | 25 | 55 | View |
| Cold Blood Cardioplegia | Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate. After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional \> 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C. | None | None | 9 | 55 | 34 | 55 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Profuse bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | No source vocabulary | View |
| Acute Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | No source vocabulary | View |
| Mediastinal bleed | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | No source vocabulary | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | Infections and infestations | No source vocabulary | View |
| CVA | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | No source vocabulary | View |
| Community acquired pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | No source vocabulary | View |
| Acute chest pain, shortness of breath | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | No source vocabulary | View |
| Atrial Fib with rapid ventricular response | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | No source vocabulary | View |
| SOB, peripheral edema, mouth pain 16 days post-op | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | No source vocabulary | View |
| Femoral occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | No source vocabulary | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | No source vocabulary | View |
| Emergent Coronary Bypass | SYSTEMATIC_ASSESSMENT | Cardiac disorders | No source vocabulary | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| A-Fib or fA-Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | No source vocabulary | View |
| Trombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | No source vocabulary | View |
| Heart Block (complete, 1st AV, 2 AV, 3 AV) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | No source vocabulary | View |
| Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | No source vocabulary | View |
| Bleeding (any) | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | No source vocabulary | View |
| Acute blood loss anemina/any anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | No source vocabulary | View |
| Junctional Rhythm | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | No source vocabulary | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | No source vocabulary | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | No source vocabulary | View |
| Acute Kidney Failure/Renal Failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | No source vocabulary | View |