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: 2025-12-26 @ 11:07 AM
Ignite Modification Date: 2025-12-26 @ 11:07 AM
NCT ID: NCT00881712
Description: None
Frequency Threshold: 0
Time Frame: Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Study: NCT00881712
Study Brief: Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PET Positive Nodal Disease Measuring 15 mm or Greater Proton radiation with concomitant chemotherapy PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy. None None 2 13 13 13 View
PET Positive Nodal Disease Measuring Less Than 15 mm Proton radiation PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy. None None 0 0 0 0 View
Patients Considered Resectable Proton radiation plus surgery Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed. None None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Weight loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Radiation dermatitis SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
White blood cell count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Bronchial stricture SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Weight loss SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Alopecia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Esophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Platelet count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View