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: 2025-12-25 @ 4:13 AM
Ignite Modification Date: 2025-12-26 @ 3:12 AM
NCT ID: NCT01768520
Description: None
Frequency Threshold: 2
Time Frame: 12Weeks
Study: NCT01768520
Study Brief: Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Entelon Tab. 150mg Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg 0 None 3 152 14 152 View
Celebrex Cap. Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg 0 None 4 147 22 147 View
Placebo Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg 0 None 1 39 16 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Multiple fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Nasolacrimal duct obstruction,Right SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.0 View
Epigastric pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Esophageal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 17.0 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Middle cerebral artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
three abscess cavities scattered in both hepatic lobes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 17.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View