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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:45 AM
NCT ID: NCT00496860
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00496860
Study Brief: Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ALT-801 0.015 mg/kg/Dose 0.015 mg/kg/dose of ALT-801 None None 0 4 4 4 View
ALT-801 0.040 mg/kg/Dose 0.040 mg/kg/dose of ALT-801 None None 2 16 16 16 View
ALT-801 0.080 mg/kg/Dose 0.080 mg/kg/dose of ALT-801 None None 4 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pleural Effusion None Respiratory, thoracic and mediastinal disorders None View
Death-NOS None General disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Cardiac Ischemia/Infarction None Cardiac disorders None View
THROMBOSIS None Vascular disorders None View
Pulmonary Infiltrates None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rhinitis None Immune system disorders None View
Hemoglobin None Blood and lymphatic system disorders None View
Lymphopenia None Blood and lymphatic system disorders None View
Platelets None Blood and lymphatic system disorders None View
Supraventricular arrhythmia - Sinus tachycardia None Cardiac disorders None View
Ventricular arrhythmia - Ventricular tachycardia None Cardiac disorders None View
Hypertension None Cardiac disorders None View
Hypotension None Cardiac disorders None View
INR None Investigations None View
Fatigue None General disorders None View
Fever None General disorders None View
Insomnia None General disorders None View
Rigors/chills None General disorders None View
Weight gain None General disorders None View
Dermatology - Other None Skin and subcutaneous tissue disorders None View
Rash/desquamation None Skin and subcutaneous tissue disorders None View
Anorexia None Metabolism and nutrition disorders None View
Constipation None Gastrointestinal disorders None View
Mucositis None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Edema: trunk/genital None Blood and lymphatic system disorders None View
Alkaline phosphatase None Investigations None View
ALT None Investigations None View
AST None Investigations None View
Bicarbonate, serum-low None Investigations None View
Bilirubin None Investigations None View
Hyperglycemia None Investigations None View
Hypocalcemia None Investigations None View
Hypokalemia None Investigations None View
Hypomagnesemia None Investigations None View
Hyponatremia None Investigations None View
Hypophosphatemia None Investigations None View
Proteinuria None Investigations None View
Dizziness None Nervous system disorders None View
Mood alteration None Nervous system disorders None View
Pain - Musculoskeletal None General disorders None View
Pain - Neurology None General disorders None View
Pain - Other None General disorders None View
Pain - Pulmonary None General disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Renal - Other - Decreased urine output None Renal and urinary disorders None View
Hypermagnesemia None Investigations None View
Hypoalbuminemia None Investigations None View
Flushing None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Diarrhea None Gastrointestinal disorders None View
Heartburn None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Infection with normal ANC None Infections and infestations None View
Edema: limb None Blood and lymphatic system disorders None View
Creatinine None Investigations None View
Hyperkalemia None Investigations None View