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 @ 5:45 PM
Ignite Modification Date: 2025-12-25 @ 3:13 PM
NCT ID: NCT00517868
Description: None
Frequency Threshold: 5
Time Frame: Adverse Event (AE) collection timeframe: for the duration of study conduct (up to 3 study visits or 5 days total) through 24 hours post-last dose of placebo or study drug Serious Adverse Event (SAE) and All-Cause Mortality (ACM) collection timeframe: for the duration of study conduct (up to 3 study visits or 5 days total) through 30 days post-last dose of placebo or study drug
Study: NCT00517868
Study Brief: Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Inclusive of all AEs following placebo dose exposures. 0 None 0 28 8 28 View
Total Inclusive of all AEs following all placebo and URG101 dose exposures. 0 None 1 28 28 28 View
URG101 Inclusive of all AEs following URG101 (study drug) dose exposures. 0 None 1 28 21 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vaginal Bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bladder Discomfort/Pain/Burning NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urethral Pain/Burn/Discomfort NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal Pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View