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 @ 6:37 PM
Ignite Modification Date: 2025-12-25 @ 4:07 PM
NCT ID: NCT00005957
Description: None
Frequency Threshold: 5
Time Frame: 10 years
Study: NCT00005957
Study Brief: Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive 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
Standard Breast Irradiation radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields. Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment. None None 1 927 745 927 View
Breast Radiation Plus Regional Radiation regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields. Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment. None None 3 893 752 893 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Secondary Malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphedema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pain due to radiation SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Joint SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Skin SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Subcutaneous tissue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Radiation dermatitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Neuropathy-sensory SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Neuropathic pain SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hot flashes/ flushes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View