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 @ 11:45 AM
Ignite Modification Date: 2025-12-26 @ 10:19 AM
NCT ID: NCT02524561
Description: There were no adverse events related to the ancillary mammographic density study.
Frequency Threshold: 0
Time Frame: baseline through 4 years.
Study: NCT02524561
Study Brief: KEEPS Mammographic Density And Breast Health Ancillary Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Estradiol Patch, Active Progesterone Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime Estradiol patch: Climara 50 mcg/day Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime Placebo tablet: Placebo tablet None None 0 162 0 162 View
Placebo Placebo tablet, placebo patch, placebo progesterone Placebo tablet: Placebo tablet Placebo patch: placebo patch Placebo progesterone: placebo progesterone None None 0 187 0 187 View
CEE Pill, Active Progesterone Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime CEE pill: Conjugated equine estrogens 0.45 mg/day Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime Placebo patch: placebo patch None None 0 168 0 168 View
Serious Events(If Any):
Other Events(If Any):