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:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
NCT ID:
NCT00587158
Description:
Adverse events were determined based on changes in clinical symptoms and changes in laboratory results at various timepoints and during study visits. Mayo Clinic management programs currently in place for renal transplant recipients with specific laboratory abnormalities were used to diagnose and manage conditions.
Frequency Threshold:
0
Time Frame:
Adverse events were monitored and collected from baseline to 52 weeks post kidney transplant.
Study:
NCT00587158
Study Brief:
Oral Paricalcitol in Kidney Transplant Recipients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Immunosuppression With Paricalcitol | Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®). | None | None | 27 | 51 | 32 | 51 | View |
| Immunosuppression Without Paricalcitol (Control) | Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®). | None | None | 16 | 49 | 14 | 49 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Orthostasis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| nausea and vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| malaise | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| liver cirrhosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| allergy to intravenous immunoglobulin | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| bone fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| right leg radicular pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| incidental renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| paranoia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| chylous ascitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| vertebral artery dissection | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| hematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| lymphocele | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| surgical incision pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| ureteric revision | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| wound complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Clostridium difficile | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Cytomegalovirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| scrotal cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Turberculosis, Active | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Upper Respiratory Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| bilateral native nephrectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| hernia repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| hysterectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| motor vehicle accident | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| ureteral revision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| biopsy complication | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| pulmonary embolus | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| peripheral vascular disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Post transplant diabetes mellitus | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (4.0) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| allergy to Bactrim | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| symptomatic hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Fall in bathroom | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Re-operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| viral (BK) nephropathy | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| BK viremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Cytomegalovirus viremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Clostridium difficile | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| bladder urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| glomerulonephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Surgical Incision Pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| Urinary Tract Infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Wound Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |