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 @ 5:53 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT01982968
Description: None
Frequency Threshold: 1
Time Frame: 48 weeks
Study: NCT01982968
Study Brief: Treatment of IPF With Laparoscopic Anti-Reflux Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Subjects to receive standard anti-reflux treatment per clinical discretion 4 None 8 29 0 29 View
Surgery Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal GER 1 None 5 29 9 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Worsening SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders None View
myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
gastrointestinal haemorrhave SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
cholecytitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
shock SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastrointestinal motility disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
incision site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View