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:
NCT04420195
Description:
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
Frequency Threshold:
0
Time Frame:
2 years.
Study:
NCT04420195
Study Brief:
Envarsus XR in Lung Transplant
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Envarsus XR | Envarsus XR to be initiated once patient is tolerating oral medications Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets. | 0 | None | 1 | 40 | 29 | 40 | View |
| Historical Controls | Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants. Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients. | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allograft failure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sepsis/pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Acute rejection | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Nausea/vomiting/diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Respiratory viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hyperglycemia/Hyperosmolar hyperglycemic state (HHS)/Diabetic ketoacidosis (DKA) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Video-assisted thoracoscopic surgery (VATS) pleurodesis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Cytomegalovirus (CMV) infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Antibody-mediated rejection | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pleural effusion/thoracentesis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Anxiety attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Mycobacterium avium-intracellulare (MAI) infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Peripheral neuropathy/pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Ureterostomy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dysphagia/aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension/syncope | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Drug overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Aspergillus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hemoptysis after transbronchial biopsy | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Cough/shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |