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 @ 10:08 PM
Ignite Modification Date: 2025-12-25 @ 7:44 PM
NCT ID: NCT01002235
Description: None
Frequency Threshold: 0
Time Frame: 365 days
Study: NCT01002235
Study Brief: Gene Therapy for Painful Diabetic 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 8 mg Subjects received Intramuscular injections of Engensis (VM202) to the calf on Days 0 and 14 0 None 0 4 2 4 View
Engensis 4 mg Subjects received Intramuscular injections of Engensis (VM202) to the calf on Days 0 and 14 0 None 0 4 3 4 View
Engensis 16 mg Subjects received Intramuscular injections of Engensis (VM202) on Days 0 and 14 0 None 0 4 2 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal vascular disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Benign prostatic hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View