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: 2025-12-25 @ 2:46 AM
Ignite Modification Date: 2025-12-26 @ 1:26 AM
NCT ID: NCT02831933
Description: None
Frequency Threshold: 0
Time Frame: From informed consent signing up to and including 30 days after the last treatment dose of Nivolumab.
Study: NCT02831933
Study Brief: Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal 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
Experimental ADV/HSV-tk (5 x 1011 viral particles) in a 2-mL total volume will be injected intratumorally on day 0 of the study. Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days. Valacyclovir treatment will be administered 24 hours after the gene vector injection from day 1 to day 15 of the study. SBRT of 30 gray (Gy; 6 Gy X 5 fractions) will be administered over 2 weeks from day 2 to day 16 of the study. Nivolumab (480 mg) will be administered intravenously over 30 minutes every 4 weeks starting on day 17 of the study and continuing until disease progression, unacceptable toxicity, or up to 12 months in patients without disease progression. ADV/HSV-tk: Replication-defective recombinant adenovirus vector Valacyclovir: Prodrug of the antiviral drug acyclovir SBRT: Low-dose SBRT nivolumab: Fully human immunoglobulin (Ig) G4 anti-PD-1 monoclonal antibody 1 None 4 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
non-traumatic intracranial hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Metabolic encephalopathy and dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Progression of disease that resulted in Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight loss NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arthritic pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cataract surgery NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Chest palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Inguinal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intractable itchiness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Loss of appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Migratory chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Psoriasiform dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Night sweats NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sleep disturbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nasal discharge NON_SYSTEMATIC_ASSESSMENT General disorders None View