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 @ 2:49 AM
Ignite Modification Date: 2025-12-26 @ 1:30 AM
NCT ID: NCT00611533
Description: None
Frequency Threshold: 0
Time Frame: Up to 16 weeks study intervention
Study: NCT00611533
Study Brief: Placebo Controlled Study of Atomoxetine in the Treatment of Mild to Moderate Cognitive Difficulties in Menopausal Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. None None 0 16 1 16 View
Atomoxetine Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. None None 0 16 2 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
increase in blood pressure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
racing heart NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
racing thoughts NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View