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 @ 2:23 AM
Ignite Modification Date: 2025-12-26 @ 12:55 AM
NCT ID: NCT04088734
Description: None
Frequency Threshold: 0
Time Frame: All-Cause Mortality: From enrollment to the end of study; mean of 18 months. Adverse Events: from first dose of study drug up to Day 454.
Study: NCT04088734
Study Brief: Gene Transfer Study of ABO-102 in Patients With Middle and Advanced Phases of MPS IIIA 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
scAAV9.U1a.hSGSH, 3x1013 vg/kg An intravenous injection of ABO-102 (scAAV9.U1a.hSGSH) via peripheral limb vein at a dose of 3.0 x 1013 vg/kg 0 None 3 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Foreign body in gastrointestinal tract SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Gastrostomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Mixed deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.1 View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Haematocrit increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Haemoglobin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Red blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Fine motor skill dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Abnormal behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Initial insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View