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: 2025-12-25 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:09 AM
NCT ID: NCT00271505
Description: None
Frequency Threshold: 5
Time Frame: through study completion, an average of 1 year
Study: NCT00271505
Study Brief: Avastin/Docetaxel/Carboplatin in 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
Carboplatin,Docetaxel, and Bevacizumab Up to 6 cycles of carboplatin (AUC 6), Tocetaxel (75 mg/m2), and Bevacizumab (15 mg/kg) on Day 1 every 21 days 2 None 13 40 25 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemoptysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Pulmonary Hemmorhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Perforation Duodenum G4 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Rt Ing Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fatigue & Infection G3 SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Mild Anemia of Chronic Disease and Fatigue SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Sudden Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Death SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nail Change SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (3.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Stomatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View