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 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
NCT ID:
NCT03816332
Description:
None
Frequency Threshold:
5
Time Frame:
Up to 3 years
Study:
NCT03816332
Study Brief:
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Nivolumab, Tacrolimus, and Prednisone | Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, and nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity. | 4 | None | 6 | 10 | 9 | 10 | View |
| Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, nivolumab 3 mg/kg by infusion and ipilimumab 1 mg/kg by infusion every 3 weeks for 4 doses followed by maintenance nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity. | 3 | None | 6 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
| Cardiac troponin | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Cardiac chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v5.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Inferior vena cava stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
| Lactic acidosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
| Pseudoaneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v5.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Small bowel obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Suspected allograft rejection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Urinary hesitancy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Viral gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v5.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v5.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Bleeding at VasCath Site | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v5.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Blood Urea Nitrogen Increased | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Cardiac troponin I increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Chest pain - cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Corneal dellan, right eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v5.0 | View |
| CPK increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v5.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Eye conjunctival tumor | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v5.0 | View |
| Eye redness | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v5.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Hepatocellular Liver Injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v5.0 | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v5.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Hyperphosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v5.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v5.0 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v5.0 | View |
| Laryngeal hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Loose Stools | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Neck stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Neutrophil Count Increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v5.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Porocarcinoma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v5.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v5.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v5.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v5.0 | View |
| Thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Tumor hemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | View |
| Tumor Malodor | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v5.0 | View |
| Tumor Odor | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Urinary hesitancy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v5.0 | View |
| White Blood cell Count Increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v5.0 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |