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 @ 9:58 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT04873232
Description: For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Frequency Threshold: 0
Time Frame: Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365.
Study: NCT04873232
Study Brief: A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Engensis Patients who have received Engensis in protocol VMDN-003-2 Engensis: Injections with Engensis in study VMDN-003-2 0 None 3 49 16 49 View
Placebo Patients who have received Placebo in protocol VMDN-003-2 Placebo: Injections with Placebo in study VMDN-003-2 0 None 6 57 22 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Post procedural cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Medra 26.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 26.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Gastoenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Post procedural cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations Medra 26.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Bundle branch block left SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders Medra 26.0 View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders Medra 26.0 View
Conjunctival oedema SYSTEMATIC_ASSESSMENT Eye disorders Medra 26.0 View
Dry age-related macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders Medra 26.0 View
Ocular hypertension SYSTEMATIC_ASSESSMENT Eye disorders Medra 26.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations Medra 26.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations Medra 26.0 View
Blood creatinine abnormal SYSTEMATIC_ASSESSMENT Investigations Medra 26.0 View
Blood urea abnormal SYSTEMATIC_ASSESSMENT Investigations Medra 26.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations Medra 26.0 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Medra 26.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Medra 26.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Medra 26.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Medra 26.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Medra 26.0 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Medra 26.0 View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 26.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 26.0 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 26.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders Medra 26.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders Medra 26.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders Medra 26.0 View
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders Medra 26.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 26.0 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 26.0 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Medra 26.0 View
Diverticulum intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 26.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 26.0 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Medra 26.0 View
Synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 26.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Medra 26.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders Medra 26.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra 26.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra 26.0 View
Colorectal adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medra 26.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders Medra 26.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Medra 26.0 View