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 @ 3:25 PM
Ignite Modification Date: 2025-12-25 @ 1:42 PM
NCT ID: NCT03475992
Description: None
Frequency Threshold: 0
Time Frame: Safety data collected over 15 months
Study: NCT03475992
Study Brief: Pilot Clinical Study on a Low-power Electromagnetic Wave Breast Imaging Device for Cancer Screening Purposes.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pre-diagnosed Breast Cancer - Biopsy Confirmed Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump 0 None 0 11 0 11 View
Pre-diagnosed Breast Cyst Low-power microwave breast imaging system. No prior biopsy Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump 0 None 0 9 1 9 View
Pre-diagnosed Benign Lesion - Biopsy Confirmed Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump 0 None 0 5 0 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eyelid infection-stye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View