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 @ 2:22 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT00368459
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00368459
Study Brief: Raloxifene for Women With Alzheimer's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Raloxifene oral raloxifene 120 mg once daily raloxifene None None 2 21 16 21 View
Placebo identical appearing oral placebo None None 1 21 13 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
colon cancer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
agitation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
death NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hallucinations NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
cold symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
decreased appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
arm or shoulder pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
sinusitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hallucinations NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
paranoia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View