Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:48 AM
Ignite Modification Date: 2025-12-26 @ 2:35 AM
NCT ID: NCT03603002
Description: None
Frequency Threshold: 0
Time Frame: Pre-SABR, Post-SABR, 3, 6, 9 and 12 months.
Study: NCT03603002
Study Brief: Pathologic and Immunologic Response After Ablative Radiation in 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
Stage I NSCLC With SABR Therapy Participants receive stereotactic ablative radiotherapy (SABR) and pre-SABR biopsy as part of standard of care and then receive a post-SABR biopsy after receiving SABR. 1 None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Cough SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Difficulty swallowing SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Dizziness SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Bronchial Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View