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 @ 4:18 PM
Ignite Modification Date: 2025-12-25 @ 2:15 PM
NCT ID: NCT03998566
Description: Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Frequency Threshold: 0
Time Frame: Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit.
Study: NCT03998566
Study Brief: Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TraceIT Tissue Spacer TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care. 3 None 6 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bile Duct Stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Death due to Disease progression/worsening of Pancreatic Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Disease recurrence in the pancreas and metastasis to the lower lobe of the right lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal disorder- Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorders- Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorders- Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemorrhagic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
High Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infections and infestations- Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infections and infestations- Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infections and infestations- Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Investigations - Other, SYSTEMATIC_ASSESSMENT Investigations None View
Musculoskeletal and connective tissue disorder- Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Nervous system disorders- Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Renal and urinary disorders - Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sleep apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Surgical and medical procedures - Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood and lymphatic system disorders - Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac disorders - Other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased Leukocytes - Grade 2 SYSTEMATIC_ASSESSMENT Investigations None View
Decreased Platelet Count - Grade 1 SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema face SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Erythmatous Injection Sites SYSTEMATIC_ASSESSMENT General disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorders - Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorders - Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions - Other SYSTEMATIC_ASSESSMENT General disorders None View
General disorders and administration site conditions - Other SYSTEMATIC_ASSESSMENT General disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hepatobiliary disorders - Other SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Investigations - Other SYSTEMATIC_ASSESSMENT Investigations None View
Kyphosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Localized edema SYSTEMATIC_ASSESSMENT General disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mild Chest Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal and connective tissue disorder - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal and connective tissue disorder - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal and connective tissue disorder - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal and connective tissue disorder - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervous system disorders - Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Occasional Leg Cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Occasional Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Oral Thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain Near Incision Site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pruiritic Injection Sites SYSTEMATIC_ASSESSMENT General disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Psychiatric disorders - Other SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Renal and urinary disorders - Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal and urinary disorders - Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular disorders - Other SYSTEMATIC_ASSESSMENT Vascular disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Decreased Neutrophils - Grade 2 SYSTEMATIC_ASSESSMENT Investigations None View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal and connective tissue disorder - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Occasional Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View