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 @ 11:13 PM
Ignite Modification Date: 2025-12-25 @ 8:47 PM
NCT ID: NCT00323869
Description: All assessments were taken after every two cycles. Evaluations were taken the first 6 weeks, then every 3 weeks
Frequency Threshold: 0
Time Frame: 6 weeks
Study: NCT00323869
Study Brief: Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed 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
Bevacizumab + Carboplatin + Gemcitabine Treatment provided in 3-week cycles: * 15 mg/kg bevacizumab Day 1 of each cycle * 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle * Carboplatin (AUC of 5 every 3 weeks) None None 28 47 17 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hemorrahage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Platetes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hypotension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hyponatreamia due to SIADH SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Bilirubin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Pulmonary Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Transaminitis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Neutrophilis/Granolocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Creatinine SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View