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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT03205605
Description: None
Frequency Threshold: 5
Time Frame: For Study Session 1 & 3, 34 h 30 min post initial patch application followed by up to 72 h phone follow up. For Study Session 2 & 4, 12 h during gel application followed by up to 72 h phone follow up. If there was an adverse event, volunteers were followed up until adverse event resolved.
Study: NCT03205605
Study Brief: Effect of Heat on Oxybutynin Release and Absorption From Oxybutynin Products
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Baseline Patch patch oxybutynin: patch 0 None 0 13 13 13 View
Baseline Gel gel oxybutynin: gel 0 None 0 13 7 13 View
Patch With Heat patch oxybutynin: patch 0 None 0 12 10 12 View
Gel With Occlusion gel oxybutynin: gel 0 None 0 12 10 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain at IV site NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
vesicle (blister) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Decreased heart rate NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Decreased blood pressure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ERYTHEMA (skin reddening) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View