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 @ 6:44 PM
Ignite Modification Date: 2025-12-25 @ 4:15 PM
NCT ID: NCT01376557
Description: Safety population
Frequency Threshold: 4
Time Frame: None
Study: NCT01376557
Study Brief: Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
75 mg LX4211 qd Subjects will receive 75 mg LX4211 once daily None None 0 57 31 57 View
200 mg LX4211 qd Subjects will receive 200 mg LX4211 once daily. None None 1 60 34 60 View
400 mg LX4211 qd Subjects will receive 400 mg LX4211 once daily. None None 2 59 26 59 View
Placebo qd Placebo: Subjects will receive placebo once daily. None None 1 60 27 60 View
200 mg LX4211 Bid Subjects will receive 200 mg LX4211 twice daily. None None 0 60 26 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deep vein thrombosis None Vascular disorders None View
Myocardial infarction None Cardiac disorders None View
Cholangitis None Hepatobiliary disorders None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
bile duct stone None Hepatobiliary disorders None View
Lower limb fracture None Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Headache None Nervous system disorders None View
Constipation None Gastrointestinal disorders None View
Upper respiratory tract infection None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Sinusitis None Infections and infestations None View
Hypertension None Vascular disorders None View
Dyspepsia None Gastrointestinal disorders None View
Pollakiuria None Renal and urinary disorders None View
Vomiting None Gastrointestinal disorders None View
Hyperglycaemia None Metabolism and nutrition disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Decreased appetite None Metabolism and nutrition disorders None View