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: 2025-12-26 @ 2:41 PM
Ignite Modification Date: 2025-12-26 @ 2:41 PM
NCT ID: NCT03018106
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected from the time the participant consented to take part in the study through the Week 12 Visit.
Study: NCT03018106
Study Brief: Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Estrogen Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks 0 None 0 1 0 1 View
Serious Events(If Any):
Other Events(If Any):