Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:20 PM
Ignite Modification Date: 2025-12-25 @ 9:02 PM
NCT ID: NCT03706456
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: From first dose of study drug up to Week 156
Study: NCT03706456
Study Brief: Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Darvadstrocel 24 mL Darvadstrocel (Cx601) 24 mL suspension of 120 million cells of expanded allogeneic adipose-derived stem cells (eASC) as an intralesional injection, once on Day 1. 0 None 11 22 18 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Calculus urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Intestinal anastomosis complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Premature labour SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 25 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acrochordon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Fistula SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View