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 @ 12:18 AM
Ignite Modification Date: 2025-12-25 @ 10:21 PM
NCT ID: NCT01139658
Description: None
Frequency Threshold: 5
Time Frame: 11 weeks
Study: NCT01139658
Study Brief: Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Total Hip Replacement Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting. None None 37 929 0 929 View
Total Knee Replacement Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting. None None 48 746 0 746 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.1 View
Device dislocation SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.1 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.1 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Phlebitis deep SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Joint dislocation postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Operative haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Patella fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Scapula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.1 View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.1 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.1 View
Metastases to lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.1 View
Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.1 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA 15.1 View
Micturition disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.1 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 15.1 View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MEDDRA 15.1 View
Patellectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MEDDRA 15.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Femoral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Haemodynamic instability SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 15.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA 15.1 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA 15.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.1 View
Abdominal strangulated hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Colonic stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Rectal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.1 View
Device related sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.1 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.1 View
Other Events(If Any):