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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT00551369
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00551369
Study Brief: Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SBRT Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy None None 1 26 19 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Peripheral sensory neuropathy None Nervous system disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinusitis [with unknown ANC] None Infections and infestations CTCAE (3.0) View
Carbon monoxide diffusing capacity decreased None Investigations CTCAE (3.0) View
Forced expiratory volume decreased None Investigations CTCAE (3.0) View
Chest wall pain None Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Joint pain None Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Cough None Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Chest pain None General disorders CTCAE (3.0) View
Fatigue None General disorders CTCAE (3.0) View
Pain [other] None General disorders CTCAE (3.0) View
Fracture None Injury, poisoning and procedural complications CTCAE (3.0) View
Back pain None Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Myositis None Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Atelectasis None Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Dyspnea None Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pneumonitis None Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pulmonary fibrosis None Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View