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 @ 2:24 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT04033159
Description: None
Frequency Threshold: 5
Time Frame: Baseline until Study termination, up to 28 months
Study: NCT04033159
Study Brief: Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Dose Cohort 1 - Low Dose DYN101 in a low dose (1.5 mg/kg), single administration 0 None 3 6 6 6 View
Single Dose Cohort 2 - Middle Dose DYN101 in a middle dose (4.5 mg/kg), single administration 0 None 2 8 8 8 View
Multiple Dose Cohort 1 - Low Dose DYN101 in a low dose (1.5 mg/kg), weekly administration 0 None 0 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cholesteatoma SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Breast mass SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Tibia fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Respiratory muscle weakness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral mucosal discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palatal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Eye complication associated with device SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site bruise SYSTEMATIC_ASSESSMENT General disorders None View
Hepatic fibrosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Immunisation reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations None View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations None View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations None View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleep disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoaesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Cystatin C increased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations None View
Total bile acids increased SYSTEMATIC_ASSESSMENT Investigations None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Investigations None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View