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 @ 1:45 AM
Ignite Modification Date: 2025-12-26 @ 12:03 AM
NCT ID: NCT02995694
Description: There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
Frequency Threshold: 0
Time Frame: 9 months
Study: NCT02995694
Study Brief: A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With 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
Test Estradiol Vaginal Cream Estradiol: Estradiol Vaginal Cream 0 None 0 215 88 215 View
Reference. Estrace Vaginal Cream Reference: Estrace Vaginal Cream 0 None 0 211 85 211 View
Placebos Placebo with no active pharmaceutical ingredients. Topical vaginal cream Placebos: Placebo with no active pharmaceutical ingredients. Topical vaginal cream 0 None 0 109 30 109 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Breast Tenderness NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Nervous System Disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders None View