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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT00227760
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00227760
Study Brief: Cediranib Maleate in Treating Patients With Recurrent or Metastatic Kidney Cancer 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 (Cediranib Maleate) Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given PO Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies None None 21 44 2 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vascular disorder - other SYSTEMATIC_ASSESSMENT Vascular disorders None View
Headache SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infection and infestations - other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View