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 @ 1:32 AM
Ignite Modification Date: 2025-12-25 @ 11:45 PM
NCT ID: NCT01336894
Description: Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Please note that the death NOS reported fell outside of the reporting window and was queried on but since the trial was terminated midstream the data management was not completed.
Frequency Threshold: 0
Time Frame: All adverse events reported since the participants received the study interventions to the date the study was closed prematurely on May 15, 2013 with no further follow up expected; up to 2 years from the start of the study.
Study: NCT01336894
Study Brief: Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung 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
Arm I (SR+Brachytherapy) Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin. None None 1 4 3 4 View
Arm II (SBRT) Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart. None None 0 7 4 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAEV4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEV4.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEV4.0 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAEV4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAEV4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAEV4.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEV4.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEV4.0 View
Carbon monoxide diffusing capacity decreased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Forced expiratory volume decreased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Vital capacity abnormal SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEV4.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEV4.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View