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 @ 9:22 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT01656304
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01656304
Study Brief: Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy
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 (Monoclonal Antibody, Antiangiogenesis) Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies None None 4 16 13 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALT increase SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
AST Increase SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Generalized Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Hemorrhage GI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhage GU SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhage GU-prostate/urethra SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhage nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hemorrhage oral cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Leukopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Lower Extremity swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Urine color change SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View