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 @ 6:44 PM
Ignite Modification Date: 2025-12-25 @ 4:15 PM
NCT ID: NCT00651157
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00651157
Study Brief: Viral Therapy in Treating Patients With Metastatic 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
Treatment (Viral Therapy) Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. None None 11 22 22 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum calcium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Ureteric obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Bronchopulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View