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 @ 5:52 PM
Ignite Modification Date: 2025-12-25 @ 3:17 PM
NCT ID: NCT00530868
Description: None
Frequency Threshold: 2
Time Frame: 24 weeks of active treatment
Study: NCT00530868
Study Brief: Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Letrozole + Avastin Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks. Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms. Hypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm. 0 None 2 50 2 50 View
Letrozole Alone Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms. Hypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm. 0 None 0 25 0 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders other View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders other View