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 @ 4:11 AM
Ignite Modification Date: 2025-12-26 @ 3:09 AM
NCT ID: NCT02068820
Description: None
Frequency Threshold: 0
Time Frame: Post-op follow up 6 weeks
Study: NCT02068820
Study Brief: Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ISB Only Adverse Events ISB only Adverse Events categories reported during post-op follow up 6 weeks None None 0 20 5 20 View
ICG Adverse Events ICG Adverse Events categories reported during post-op follow up 6 weeks None None 0 180 29 180 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory, thoracic, and pulmonary complications SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac complications SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vascular complications SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gastrointestinal complications SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders None View
Blood and lymphatic system complications SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Reproductive system complications SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Renal and urinary complications SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Wound complications SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View