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 @ 11:47 AM
Ignite Modification Date: 2025-12-26 @ 10:20 AM
NCT ID: NCT00726661
Description: SAEs and other AEs were collected for all enrolled participants.
Frequency Threshold: 0
Time Frame: Approximately 4.5 years
Study: NCT00726661
Study Brief: An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chemotherapy Cohort Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). None None 76 832 46 832 View
Hormonal Therapy Cohort Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). None None 22 435 13 435 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Severe thrush NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Femoral neck fracture right hip NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombosis/embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombosis/thrombus/embolism - pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Neutropenic fever NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute systolic heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Recurrent transient ischemic attack NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Perforated diverticulum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hepatic insufficiency related to metastatic breast cancer NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abdominal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection peritioneal cavity NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Malignant pleural effusion NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Acute left occipital infarct NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cord compression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemorrhagic mass in brain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Perforation colon (Grade 1) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization for weakness that ended in death (cause unknown) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Abdominal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Acute pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bilateral pulmonary emboli NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis (nose hemorrhage) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Left lung atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary emboli NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism Grade 3 NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolization NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bilateral leg ulcers NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cellulitis of the left upper extremity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Left heel ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arterial thromboembolic events NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Elevated blood pressure NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Moderate size infarct involving a portion of the right middle cerebral artery territory NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Multi-organ failure (shock) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Severe venous thromboembolic event (Grade > =4) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Heart attack NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular systolic dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular systolic dysfunction (Grade >=2) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular systolic dysfunction (Grade 3) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular systolic dysfunction (Grade 4) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion with impending tamponade NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Incarcerated umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intractable nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Persistant vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Viral gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection-left breast NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Line associated bacteremia (vascular chest port infection) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intertrochanteric hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypercalcemeia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Joint pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain musculoskeletal joint NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pathologic fracture of the femur NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
T4 intramedullary mass NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Metabolic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Posterior reversible encephtalopathy syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Polyneuropathy NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bilateral subdural hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenic sepsis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiopulmonary arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery ischemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Recurrent right pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Jaw pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tingling in fingers grade I NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy of toes and clinical progression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizzy spells NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arterial thromboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infusion reaction Grade II NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Left ventricular systolic dysfunction (Grade >=2) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain-musculoskeletal-joint NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nail toxicity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bilateral hand neuropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral neuropathy (Grade >=3) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral neuropathy (motor or sensory) (grade >= 3) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensory neuropathy grade 2 NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epigastric pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Decreased ejection fraction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bicytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Worsening anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Myelosuppression NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Intermittent nosebleeds grade 1 NON_SYSTEMATIC_ASSESSMENT Investigations None View
Malignant pleural effusion indicating disease progression NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous thromboembolic event (Grade > =4) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infusional reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Osteonecrosis of the jaw NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View