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 @ 6:31 PM
Ignite Modification Date: 2025-12-25 @ 4:01 PM
NCT ID: NCT01471457
Description: Adverse events are worsening of vaginal symptoms since pessary fitting; this could be treatment related or not treatment related Serious adverse events were any recorded events that required hospitalization or were life-threatening, whether related or unrelated to treatment
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT01471457
Study Brief: Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Trimo-San Group Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly Trimo-San gel: Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly 0 None 0 92 18 92 View
Control Group Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel 0 None 0 92 13 92 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Any vaginal symptom attributable possibly to pessary NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View