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 @ 10:41 PM
Ignite Modification Date: 2025-12-25 @ 8:12 PM
NCT ID: NCT04669535
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were captured from screening prior to treatment until the subjects were all moved to long-term follow-up and the initial study was closed. This time ranged from 9 months for the most recently treated patient to 3 years for the patient who was the furthest from their treatment date at the time of moving to long-term follow-up.
Study: NCT04669535
Study Brief: A Dose-escalation and Safety & Efficacy Study of AXO-AAV-GM2 in Tay-Sachs or Sandhoff Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AXO-AAV-GM2 Starting Dose All subjects treated with AXO-AAV-GM2 Starting Dose 1 None 1 1 1 1 View
AXO-AAV-GM2 Low Dose All subjects treated with AXO-AAV-GM2 Low Dose 1 None 3 3 3 3 View
AXO-AAV-GM2 Middle Dose All subjects treated with AXO-AAV-GM2 Middle Dose 0 None 3 3 3 3 View
AXO-AAV-GM2 High Dose All subjects treated with AXO-AAV-GM2 High Dose 0 None 1 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Aspiration pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza A SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death due to disease progression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental status changes SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological decompensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bronchiolitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophil Count Decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Otitis Media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eyelid Edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Subconjunctival Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Coffee Ground Emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Rigors SYSTEMATIC_ASSESSMENT General disorders None View
Surgery-related Pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Surgical Site Swelling SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Surgical Wound Drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Abnormal Results of Liver Function Studies SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anti-Capsid immune response by ELISpot SYSTEMATIC_ASSESSMENT Immune system disorders None View
Seasonal Allergies SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium Difficile Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
G-Tube Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pediculosis Capitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
PICC Line Related Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Abnormal Movements SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Delayed recovery from anesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Disease Progression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Macrocephaly SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tardive dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ventriculomegaly SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypersalivation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increased Mucus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Laryngospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis Contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis Diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis due to adhesive SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis Seborrheic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Incision Site Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Petechia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scalp Induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Perioral Cyanosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Premature Ventricular Contractions SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Run of Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Procedure-related pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Covid-19 Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laryngospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis Diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infusion Related Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View