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 @ 9:08 PM
Ignite Modification Date: 2025-12-25 @ 6:59 PM
NCT ID: NCT02527304
Description: None
Frequency Threshold: 0
Time Frame: Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Study: NCT02527304
Study Brief: Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot 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
Treatment (Adaptive Staged SBRT) Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT 0 None 0 24 5 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Urinary Frequency (Increased) SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Conjuctivitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Rash (nonspecific) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View