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 @ 1:14 AM
Ignite Modification Date: 2025-12-25 @ 11:24 PM
NCT ID: NCT00072293
Description: Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.
Frequency Threshold: 0
Time Frame: 5-years. Treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema and motor neuropathy) at every follow-up visit (every 4 months from date of randomization for the first year and every six months from years 2-5).
Study: NCT00072293
Study Brief: Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Axillary Dissection Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. Axillary lymph node dissection: Axillary lymph node dissection None None 1 447 178 447 View
No Axillary Dissection Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. No axillary lymph node dissection: Therapeutic conventional surgery None None 0 453 83 453 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Post-operative infection (L.axilla) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View