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 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT00334893
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00334893
Study Brief: Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube 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
Platinum-Resistant Disease Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. eribulin mesylate : Given IV None None 17 36 16 36 View
Platinum-Sensitive Disease Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. eribulin mesylate : Given IV None None 16 37 19 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac ischemia/infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Death NOS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Death-Disease progression SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hemoglobin decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Leukocyte count decrease/white blood cell decrease SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Neutrophil count decrease SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Obstruction-GI-Colon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pain-Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Pain-Chest wall SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Phosphate, low (hypophosphatemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Thrombosis/thrombus/embolism SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Neurological disorder SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Perforation, GI-Small Bowel NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 3.0 View
Lymphocyte count decrease SYSTEMATIC_ASSESSMENT Investigations CTCAE v 3.0 View
Neutrophil count decrease SYSTEMATIC_ASSESSMENT Investigations CTCAE v 3.0 View
White blood cell decrease SYSTEMATIC_ASSESSMENT Investigations CTCAE v 3.0 View
AST/SGOT increase SYSTEMATIC_ASSESSMENT Investigations CTCAE v 3.0 View