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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
NCT ID:
NCT04688658
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events data collected for up to 42.5 months for the study population.
Study:
NCT04688658
Study Brief:
Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Duvelisib (25mg) + Nivolumab (240mg) | Phase 1: Duvelisib, 25mg once a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab. Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor) | 5 | None | 4 | 6 | 6 | 6 | View |
| Duvelisib (15mg) + Nivolumab (240mg) | Phase 1: Duvelisib,15mg once a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab. Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor) Phase II: The Recommended Phase II dosage of duvelisib administered will not be determined until Phase I is completed. Nivolumab, 480mg, IV, every 4 weeks, for up to 1 year. Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. | 7 | None | 6 | 7 | 7 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | CARDIAC DISORDERS | CTCAE (5.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | View |
| Retroperitoneal hemorrhage | SYSTEMATIC_ASSESSMENT | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | HEPATOBILIARY DISORDERS | CTCAE (5.0) | View |
| Covid | SYSTEMATIC_ASSESSMENT | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) -Other, specifyBrain |Neoplasm | SYSTEMATIC_ASSESSMENT | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) | CTCAE (5.0) | View |
| Edema cerebral | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | PSYCHIATRIC DISORDERS | CTCAE (5.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | RENAL AND URINARY DISORDERS | CTCAE (5.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | View |
| sternectomy with reconstruction | SYSTEMATIC_ASSESSMENT | SURGICAL AND MEDICAL PROCEDURES | CTCAE (5.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Prothrombin time increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | CTCAE (5.0) | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | CTCAE (5.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | CTCAE (5.0) | View |
| Dysphasia | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | PSYCHIATRIC DISORDERS | CTCAE (5.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | PSYCHIATRIC DISORDERS | CTCAE (5.0) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | PSYCHIATRIC DISORDERS | CTCAE (5.0) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | PSYCHIATRIC DISORDERS | CTCAE (5.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | RENAL AND URINARY DISORDERS | CTCAE (5.0) | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | RENAL AND URINARY DISORDERS | CTCAE (5.0) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | RENAL AND URINARY DISORDERS | CTCAE (5.0) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | RENAL AND URINARY DISORDERS | CTCAE (5.0) | View |
| Glucosuria | SYSTEMATIC_ASSESSMENT | RENAL AND URINARY DISORDERS | CTCAE (5.0) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | RENAL AND URINARY DISORDERS | CTCAE (5.0) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | RENAL AND URINARY DISORDERS | CTCAE (5.0) | View |
| Urine discoloration | SYSTEMATIC_ASSESSMENT | RENAL AND URINARY DISORDERS | CTCAE (5.0) | View |
| Reproductive system and breast disorders - |Other, specifyLabial |Lesion |Pain | SYSTEMATIC_ASSESSMENT | REPRODUCTIVE SYSTEM AND BREAST DISORDERS | CTCAE (5.0) | View |
| Reproductive system and breast disorders - |Other, specifypain (labia) | SYSTEMATIC_ASSESSMENT | REPRODUCTIVE SYSTEM AND BREAST DISORDERS | CTCAE (5.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | View |
| Respiratory, thoracic and mediastinal disorders - |Other, specifyHemoptysis | SYSTEMATIC_ASSESSMENT | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | View |
| Surgical and medical procedures - |Other, specifyCraniotomy | SYSTEMATIC_ASSESSMENT | SURGICAL AND MEDICAL PROCEDURES | CTCAE (5.0) | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | View |
| deep tissue pressure injury on buttocks | SYSTEMATIC_ASSESSMENT | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | VASCULAR DISORDERS | CTCAE (5.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | VASCULAR DISORDERS | CTCAE (5.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | VASCULAR DISORDERS | CTCAE (5.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | BLOOD AND LYMPHATIC SYSTEM DISORDERS | CTCAE (5.0) | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | BLOOD AND LYMPHATIC SYSTEM DISORDERS | CTCAE (5.0) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | BLOOD AND LYMPHATIC SYSTEM DISORDERS | CTCAE (5.0) | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | CARDIAC DISORDERS | CTCAE (5.0) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | CARDIAC DISORDERS | CTCAE (5.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | CARDIAC DISORDERS | CTCAE (5.0) | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | ENDOCRINE DISORDERS | CTCAE (5.0) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | EYE DISORDERS | CTCAE (5.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| lymph node pain | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| restlessness | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | View |
| Bruising | SYSTEMATIC_ASSESSMENT | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | CTCAE (5.0) | View |
| Pain - Surgical | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Generalized edema | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | View |
| Thrush | SYSTEMATIC_ASSESSMENT | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Cardiac troponin I increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| CD4 lymphocytes decreased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| INR increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Elevated CRP | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Partial thromboplastin time increased | SYSTEMATIC_ASSESSMENT | INVESTIGATIONS | CTCAE (5.0) | View |
| Tumor |Pain - |Chest | SYSTEMATIC_ASSESSMENT | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | View |