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 @ 12:14 PM
Ignite Modification Date: 2025-12-25 @ 12:01 PM
NCT ID: NCT04213261
Description: All treatment-emergent AEs, regardless of relationship to FCX-007, are reported. AEs at a treated wound were to be described and coded as injection site reactions, AEs at other wounds (including but not limited to control wounds) were described without specific reference to injection-site. Only a single interventional group is included, inclusive of all study participants who have received FCX-007 and had at least one control wound.
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events (AEs), regardless of relationship to FCX-007, are those reported from start of treatment to end of treatment period (Week 48)
Study: NCT04213261
Study Brief: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa
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 COL7A1 Genetically-Corrected Autologous Fibroblasts Intra-subject randomized (paired wounds in each subject receive experimental treatment, FCX-007, or remain untreated). Up to three target wound pairs will be identified for each subject. Following pairing, target wounds will be randomly assigned as the treatment wound (FCX-007 is administered) or control wound. Subjects will receive intradermal injections of FCX-007 in each specified treatment wound in two or more treatment sessions. The first treatment session occurs at Day 1 and the second at Week 12/Month 3. Additional treatment sessions may occur at Week 24/Month 6 and Week 36/Month 9 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated. FCX-007 (dabocemagene autoficel; see below for FCX-007 description): FCX-007 is comprised of fibroblasts isolated from the subject's skin biopsies which are genetically corrected with the full length COL7A1 gene encoding for type VII collagen. 0 None 2 6 2 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (25.0) View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (25.0) View
Pulmonary infarction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (25.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (25.0) View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (25.0) View
Growth retardation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (25.0) View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (25.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (25.0) View
Superficial vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (25.0) View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA (25.0) View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA (25.0) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.0) View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.0) View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.0) View