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 @ 10:09 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT04508335
Description: Definition of adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition. (Non-treatment related Other (Not Including Serious) Adverse Events were not reported in the trial.)
Frequency Threshold: 5
Time Frame: Through study completion, an average of 16 weeks
Study: NCT04508335
Study Brief: Feasibility Study of the Reia Vaginal Pessary
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reia Pessary Reia Pessary: No. of subjects with AE new and/or worsening with Reia pessary 1 None 1 62 51 62 View
Current Pessary Current Pessary: No. subjects experience AE while being treated with their current pessary but improving with Reia pessary 0 None 0 62 55 62 View
Persisting Across Pessary Type No. of subjects with AE persisting across current and Reia pessary 0 None 0 62 55 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Symptomatic coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vaginal Discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Vaginal Bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Sensation of Displacement SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Granulation Tissue SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Discomfort with Use SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Vaginal Abrasions SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Vaginal Irritation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (Unspecified) View
Feeling of Obstructed Urination SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Constipation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View