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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:31 PM
NCT ID: NCT02810951
Description: Adverse events were reported on the whole participant level and not segmented to treated or control wounds
Frequency Threshold: 5
Time Frame: 52 weeks
Study: NCT02810951
Study Brief: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FCX-007 In Phase I, a target of three adult subjects will be enrolled into Group A and a target of three adult subjects will be enrolled into Group B. In Phase II the study will target enrolling subjects (aged seven (7) or older) to each arm, but will allow a disproportionate distribution of subjects between Group A and Group B to equal approximately 6 total subjects. All subjects will receive FCX-007 into intact skin as well as to one or more paired target wounds at least one time during the study with a possible second administration pending laboratory results. One wound in each target wound pair will be used as control for efficacy and safety evaluations. FCX-007 administered wounds will be compared within paired target wounds to untreated wounds. FCX-007: FCX-007 is a genetically modified cell product obtained from the subject's own skin cells (Autologous fibroblasts). The cells are expanded and genetically modified to produce functional collagen VII. FCX-007 cell suspension is injected intradermally. 1 None 3 6 3 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neoplasm progression NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous cell carcinoma of skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Injection site discolouration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders None View