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 @ 11:32 PM
Ignite Modification Date: 2025-12-25 @ 9:20 PM
NCT ID: NCT00816556
Description: Subjects also completed the Symptoms Inventory Questionnaire at baseline, 2, 4, 8, and 12 weeks. If subjects experienced a serious adverse event they were to be withdrawn from the study. These events included elevated blood pressure, a breakdown of vulvar or vaginal skin, or possible allergy to the medication.
Frequency Threshold: 0
Time Frame: The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred.
Study: NCT00816556
Study Brief: A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Estriol Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks None None 0 18 3 18 View
Estradiol Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks None None 0 19 0 19 View
Placebo Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks None None 0 19 1 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Red Bumpy Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTEP 3.0 View
Vaginal Spotting SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTEP 3.0 View
Breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTEP 3.0 View