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 @ 4:44 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT01340066
Description: Subjects were queried concerning AEs at all visits.
Frequency Threshold: 5
Time Frame: AEs were collected from the time of informed consent to the end of the study (6 weeks)
Study: NCT01340066
Study Brief: Safety and Efficacy Study of a New Treatment for Symptoms of 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
Non-Randomized Subjects Adverse Events (AEs) captured for subjects that were not randomized None None 0 27 0 27 View
UISH001 Subjects were treated with UISH001 during double blind treatment period. None None 1 34 15 34 View
Matching Placebo Subjects were treated with matching placebo during double blind treatment period. None None 0 33 7 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View