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 @ 4:46 PM
Ignite Modification Date: 2025-12-25 @ 2:33 PM
NCT ID: NCT01624350
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01624350
Study Brief: A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Permacol Collagen Paste None None None 6 100 29 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anal fistula None Gastrointestinal disorders None View
Anal Abscess None Infections and infestations None View
Complex regional pain syndrome None Nervous system disorders None View
Pregnancy None Pregnancy, puerperium and perinatal conditions None View
Procedural pain None Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia None Cardiac disorders None View
Anal Fissure None Gastrointestinal disorders None View
Anal Fistula None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Haemorrhoids None Gastrointestinal disorders None View
Rectal Haemorrhage None Gastrointestinal disorders None View
Pain None General disorders None View
Anal abscess None Infections and infestations None View
Infected fistula None Infections and infestations None View
Pilonidal cyst None Infections and infestations None View
pneumonia None Infections and infestations None View
postoperative wound infection None Infections and infestations None View
facial bones fracture None Injury, poisoning and procedural complications None View
procedural pain None Injury, poisoning and procedural complications None View
Complex regional pain syndrome None Nervous system disorders None View
pregnancy None Pregnancy, puerperium and perinatal conditions None View
breast mass None Reproductive system and breast disorders None View
Asthma None Respiratory, thoracic and mediastinal disorders None View
eczema None Skin and subcutaneous tissue disorders None View
hypertrophic scar None Skin and subcutaneous tissue disorders None View
Ear Pain None Ear and labyrinth disorders None View
Constipation None Gastrointestinal disorders None View
Proctalgia None Gastrointestinal disorders None View
Anal fistula infection None Infections and infestations None View
purulent discharge None Infections and infestations None View
Seroma None Injury, poisoning and procedural complications None View
decubitus ulcer None Skin and subcutaneous tissue disorders None View
haemorrhage None Vascular disorders None View