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 @ 7:21 PM
Ignite Modification Date: 2025-12-25 @ 5:00 PM
NCT ID: NCT04625803
Description: Grade ≥3 adverse events occurred in 83.3% of patients, including neutropenia, decreased white blood cell count, thrombocytopenia, hypertension and alanine aminotransferase (ALT) increase.
Frequency Threshold: 0
Time Frame: 2 year
Study: NCT04625803
Study Brief: Neoadjuvant Therapy for Locally Advanced Colon 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
Neutropenia the most common adverse events were neutropenia (83.3%) 0 None 10 12 8 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
decreased white blood cell count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hypertension NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ALT increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RCCEP SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View