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: 2025-12-24 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:45 PM
NCT ID: NCT02596451
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02596451
Study Brief: To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd) None None 0 383 28 383 View
Reference Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) None None 2 382 26 382 View
Placebo Vehicle gel (Glenmark Pharmaceuticals Ltd) None None 1 378 23 378 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
L Ankle Surgery Secondary To Trimalleolar Fracture SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Right Ankle Surgery Due To Stair Fall SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rib Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View