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 @ 2:43 PM
Ignite Modification Date: 2025-12-25 @ 1:13 PM
NCT ID: NCT00742859
Description: None
Frequency Threshold: 3
Time Frame: Maximum of 1 year
Study: NCT00742859
Study Brief: Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Betrixaban 60 mg Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months 68 None 12 127 68 127 View
Betrixaban 80 mg Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months 53 None 11 127 53 127 View
Warfarin Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months 50 None 12 127 50 127 View
Betrixaban 40 mg Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months 61 None 12 127 61 127 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sick Sinus Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cardiac Neoplasm Unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chronic Lymphocytic Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Colon Cancer Recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung Neoplasm Malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetes Mellitus Inadequate Control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fluid Overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Grand Mal Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lumbar Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abdominal Hernia Obstructive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ligament Disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arterial Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Inappropriate Antidiuretic Hormone Secretion SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Internaional Normalised Ratio Increased SYSTEMATIC_ASSESSMENT Investigations None View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Prostatic Obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders None View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations None View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LIVER FUNCTION TEST ABNORMAL SYSTEMATIC_ASSESSMENT Investigations None View