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 @ 10:34 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT00790335
Description: None
Frequency Threshold: 5
Time Frame: Serious adverse events were collected throughout the study - i.e. through 24 months post-randomization. Non-serious adverse events were collected through 30 days post-randomization, and through 30 days after any subsequent PCDT procedure.
Study: NCT00790335
Study Brief: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A-Intervention PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device. 7 None 109 336 0 336 View
B-Control Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed 8 None 86 355 0 355 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lactic acidosis, acute sepsis, atrial fibrillation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Left C4-C5 neuroforaminal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left hip removal of hardware and total hip arthoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Post-operative infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post-percardiotomy syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Left lower extremity pain and abscess SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg pain and swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg swelling SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Low hemoglobin SYSTEMATIC_ASSESSMENT Investigations None View
Blurred vision and diffuse itching SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Mania, bizarre behavior, agitation SYSTEMATIC_ASSESSMENT Investigations None View
Breast intraductal papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Broken ribs SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
C5 on C6 retrolisthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain/asthma exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest pain and shortness of breath SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain, shortness of breath, hemoptysis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Massive closed head injury SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Colon cancer - adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Complex gouty septic olecranon bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease and hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Death secondary to metastatic gastric carcinoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Debridement of right below-the-knee amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetic nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Disconnected VP shunt SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diverticulosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DVT and PE SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea with lower extremity edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elevated INR SYSTEMATIC_ASSESSMENT Investigations None View
Elevated troponin SYSTEMATIC_ASSESSMENT Investigations None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Esophageal stricture SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fall after alcohol abuse SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Foot pain/burning SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fracture and cellulitis of right first toe SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fractured humerus and ribs - fell off ladder SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gangrene left hallux SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastric adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Gastrointestinal bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gunshot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemoperitoneum of unknown etiology SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hemorrhagic cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemorrhagic shock SYSTEMATIC_ASSESSMENT Vascular disorders None View
Heparin induced thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Herniated lumbar disc SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypertensive urgency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertensive urgency with CHF exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypovolemic shocck SYSTEMATIC_ASSESSMENT Vascular disorders None View
Mediastinal adenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoxia due to hypoventilation due to multiple pain medications SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Influenza A SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intertigo labialis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Intra-abdominal fluid collection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intra-abdominal fluid collection secondary to bile leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intra-abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute phencyclidine intoxication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute rejection (heart transplant) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute right lower extremity DVT and acute bronchitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute short bowel obstruction versus Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Immune system disorders None View
Acute viral gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Adenocarcinoma of unknown primary SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Alcohol intoxication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alcohol Withdrawal SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Altered mental state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Angioedema, unclear etiology SYSTEMATIC_ASSESSMENT Immune system disorders None View
Antral gastritic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arterial occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aspiration pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asystole SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter with rapid ventricular response SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atypical chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back spasm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bilateral lower extremity cellulitis and CHF SYSTEMATIC_ASSESSMENT Infections and infestations None View
Biliary diskinesia and sludge SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bleeding at sheath puncture site SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute on chronic pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute on chronic respiratory insufficiency SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bleeding from wound SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding gums SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peripheral arterial disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleuritic chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia and pulmonary hypertension likely due to PE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Severe bilateral knee degenerative joint disease SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Short-term memory impairment of uncertain etiology SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Ventricular perforation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Viral gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomoting and diarrhea SYSTEMATIC_ASSESSMENT Infections and infestations None View
Venous thromboembolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Retroperitoneal bleed SYSTEMATIC_ASSESSMENT Vascular disorders None View
Metastatic adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abnormal lab results secondary to undetermined infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute and progressive cauda equina syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute arterial limb ischemia of left lower extremity SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute CHF with atrial fibrillation and rapid ventricular response SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acute diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute gallstone pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute oxycodone and doxylamine intoxication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Aortic insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Degenerative joint disease with total right hip replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Kidney cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic lung cancer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Migrated VP shunt SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Motor vehicle accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Methicillin-resistant Staphylococcus Aureus - wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Multisystem organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Nausea and vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea, vomiting, diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-ST wave myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Obstipation with ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Obstructing ureteral stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Orthostatic hyptension secondary to beta blockers and dehydration SYSTEMATIC_ASSESSMENT Vascular disorders None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pancreatic cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Papillary thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Perihepatic abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Renal vein obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Reversible cerebral vasoconstriction syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Right foot amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Right hand abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Right knee hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Right knee tear of medial meniscus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ruptured ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Sarcoidosis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis and pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Serum sickness SYSTEMATIC_ASSESSMENT Immune system disorders None View
Spinal headache SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Squamous cell carcinoma of unknown primary SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Staph infection in right shoulder SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subdural hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation and alcohol withdrawal SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Surgical excision of squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Suspected infection to stump from right below-knee amputation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope and head contusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Transient dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischemia attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Type A ascending aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection and cellulitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Uterine bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Uterine cancer SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):