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 @ 2:01 AM
Ignite Modification Date: 2025-12-26 @ 12:25 AM
NCT ID: NCT02396160
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02396160
Study Brief: The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment 2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs None None 0 69 5 69 View
Placebo identical placebo vegetarian capsule containing color-matched cellulose Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment None None 0 73 8 73 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Episodes of diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Headache and worsened asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsened memory SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Facial flushing SYSTEMATIC_ASSESSMENT General disorders None View
Halitosis SYSTEMATIC_ASSESSMENT General disorders None View
Worsened arthritic pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View