Adverse Events Module

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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 @ 5:28 PM
Ignite Modification Date: 2025-12-25 @ 3:02 PM
NCT ID: NCT04234568
Description: None
Frequency Threshold: 0
Time Frame: Up to 2 years
Study: NCT04234568
Study Brief: Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Escalation Phase Dose Level 1 (100mg Triapine) Patients receive lutetium Lu 177 dotatate IV for 30 to 40 minutes on day 1 of each cycle and triapine PO on days 1 throughout 14 of each cycle. Cycles repeat every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI scan throughout the trial. Patients undergo blood specimen collection on study. Biospecimen Collection: Correlative studies Computed Tomography: Undergo CT Lutetium Lu 177 Dotatate: Given IV Magnetic Resonance Imaging: Undergo MRI Triapine: Given PO 0 None 3 3 3 3 View
Escalation Phase Dose Level 2 (150mg Triapine) Patients receive lutetium Lu 177 dotatate IV for 30 to 40 minutes on day 1 of each cycle and triapine PO on days 1 throughout 14 of each cycle. Cycles repeat every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI scan throughout the trial. Patients undergo blood specimen collection on study. Biospecimen Collection: Correlative studies Computed Tomography: Undergo CT Lutetium Lu 177 Dotatate: Given IV Magnetic Resonance Imaging: Undergo MRI Triapine: Given PO 2 None 8 11 11 11 View
Escalation Phase Dose Level 3 (200mg Triapine) Patients receive lutetium Lu 177 dotatate IV for 30 to 40 minutes on day 1 of each cycle and triapine PO on days 1 throughout 14 of each cycle. Cycles repeat every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI scan throughout the trial. Patients undergo blood specimen collection on study. Biospecimen Collection: Correlative studies Computed Tomography: Undergo CT Lutetium Lu 177 Dotatate: Given IV Magnetic Resonance Imaging: Undergo MRI Triapine: Given PO 0 None 1 1 1 1 View
Expansion Phase Dose Level 1 (100mg Triapine) Patients receive lutetium Lu 177 dotatate IV for 30 to 40 minutes on day 1 of each cycle and triapine PO on days 1 throughout 14 of each cycle. Cycles repeat every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI scan throughout the trial. Patients undergo blood specimen collection on study. Biospecimen Collection: Correlative studies Computed Tomography: Undergo CT Lutetium Lu 177 Dotatate: Given IV Magnetic Resonance Imaging: Undergo MRI Triapine: Given PO 0 None 2 2 2 2 View
Expansion Phase Dose Level 2 (150mg Triapine) Patients receive lutetium Lu 177 dotatate IV for 30 to 40 minutes on day 1 of each cycle and triapine PO on days 1 throughout 14 of each cycle. Cycles repeat every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI scan throughout the trial. Patients undergo blood specimen collection on study. Biospecimen Collection: Correlative studies Computed Tomography: Undergo CT Lutetium Lu 177 Dotatate: Given IV Magnetic Resonance Imaging: Undergo MRI Triapine: Given PO 2 None 11 14 14 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v. 5.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v. 5.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Hepatic hemorrhage SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE v. 5.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE v. 5.0 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v. 5.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v. 5.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v. 5.0 View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE v. 5.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v. 5.0 View
Peritoneal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v. 5.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v. 5.0 View
Methemoglobinemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v. 5.0 View
Aortic Valve Disease SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v. 5.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v. 5.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v. 5.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v. 5.0 View
Tricuspid valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v. 5.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Gastrointestinal disorders - Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE v. 5.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE v. 5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v. 5.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v. 5.0 View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE v. 5.0 View
General disorders and administration site conditions - Other SYSTEMATIC_ASSESSMENT General disorders CTCAE v. 5.0 View
Infections and infestations - Other SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v. 5.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v. 5.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v. 5.0 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v. 5.0 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v. 5.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Investigations - Other SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hypoalbuminnemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v. 5.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v. 5.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v. 5.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v. 5.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v. 5.0 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v. 5.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v. 5.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v. 5.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v. 5.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v. 5.0 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v. 5.0 View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v. 5.0 View
Urine discolaration SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v. 5.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v. 5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v. 5.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v. 5.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v. 5.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v. 5.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v. 5.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v. 5.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v. 5.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v. 5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v. 5.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v. 5.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v. 5.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v. 5.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v. 5.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v. 5.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v. 5.0 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v. 5.0 View
Eye disorders -other SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v. 5.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v. 5.0 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders CTCAE v. 5.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v. 5.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v. 5.0 View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v. 5.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v. 5.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v. 5.0 View
INR increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v. 5.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v. 5.0 View
Musculoskeletal and connective tissue disorder - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v. 5.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v. 5.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v. 5.0 View
Dysesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v. 5.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v. 5.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v. 5.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v. 5.0 View
Renal calculi SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v. 5.0 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v. 5.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v. 5.0 View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v. 5.0 View
Skin and subcutaneous tissue disorders - other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v. 5.0 View
Vascular disorders - other SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v. 5.0 View