Acute Venous Thrombosis: Thrombus Removal With Adjunctive... | NCT00790335

ID	Type	Description	Link
U01HL088476-01A1	U.S. NIH Grant/Contract		View source

Name	Class
McMaster University	OTHER
Ontario Clinical Oncology Group (OCOG)	OTHER
National Heart, Lung, and Blood Institute (NHLBI)	NIH
BSN Medical Inc

Label	Type	Description	Intervention Names
A-Intervention	Experimental	PCDT with intrathrombus delivery of recombinant tissue plasminogen activator (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	Drug: Recombinant tissue plasminogen activator (rt-PA)
B-Control	No Intervention	Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target international normalized ratio 2.0 - 3.0). Elastic compression stockings will be prescribed

Name	Type	Description	Arm Group Labels	Other Names
Recombinant tissue plasminogen activator (rt-PA)	Drug	Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Measure	Description	Time Frame
Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)	Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.	Between 6 and 24 months after randomization

Measure	Description	Time Frame
Major Non-post-thrombotic Syndrome Treatment Failure	A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.	Through 24 months

Name	Affiliation	Role
Suresh Vedantham, M.D.	Clinical Coordinating Center at Washington University School of Medicine	Principal Investigator
Clive Kearon, MB, MRCP, FRCP(C), PhD	Data Coordinating Center at McMaster University-Ontario Clinical Oncology Group	Principal Investigator
Samuel Z Goldhaber, M.D.	Brigham and Women's Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Arrowhead Hospital/Phoenix Heart, PLLC		Glendale	Arizona	85306	United States
St. Joseph Hospital

PubMed Identifier	Type	Citation	Retractions
18574272	Background	Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):454S-545S. doi: 10.1378/chest.08-0658.
16475040	Background	Kahn SR. The post-thrombotic syndrome: the forgotten morbidity of deep venous thrombosis. J Thromb Thrombolysis. 2006 Feb;21(1):41-8. doi: 10.1007/s11239-006-5574-9.

Label	URL
Deep Vein Thrombosis	View source

ID	Title	Description
FG000	A-Intervention	Pharmacomechanical catheter-directed thrombolysis (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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)

Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.

Modified full analysis set; intention-to-treat

Posted

Count of Participants

Participants

Between 6 and 24 months after randomization

ID	Title	Description
OG000	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.
OG001	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

Units	Counts
Participants	OG000336 OG001355

Title

Denominators

Categories

Title	Measurements
	OG000157 OG001171

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	Adjusted for extent of DVT and for clinical center	0.56		Risk Ratio (RR)	0.96			2-Sided	95	0.82	1.11			Numerator: PCDT Arm; Denominator: Control Arm. Primary outcome = no statistically significant difference between the two arms.		Superiority

Secondary

Major Non-post-thrombotic Syndrome Treatment Failure

A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.

Modified full analysis set; intention to treat

Posted

Count of Participants

Participants

Through 24 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Any Treatment Failure

Composite of PTS and major non-PTS treatment failure

Modified full analysis set; intention to treat

Posted

Count of Participants

Participants

Through 24 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Moderate-to-severe Post-thrombotic Syndrome

Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.

Modified full analysis set, intention-to-treat

Posted

Count of Participants

Participants

Between 6 and 24 months after randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Major Bleeding

Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).

Modified full analysis set, intention-to-treat

Posted

Count of Participants

Participants

Within 10 days after randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Major Bleeding

Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).

Modified full analysis set; intention-to-treat

Posted

Count of Participants

Participants

Within 24 months after randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Any (Minor + Major) Bleeding

Clinically overt bleeding that occurred through 10 days post-randomization

Modified full analysis set, intention-to-treat

Posted

Count of Participants

Participants

Within 10 days after randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Any (Major + Minor) Bleeding

Clinically overt bleeding that occurred within 24 months post-randomization

Modified full analysis set, intention-to-treat

Posted

Count of Participants

Participants

Within 24 months after randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Recurrent Venous Thromboembolism

Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)

Posted

Count of Participants

Participants

Within 10 days after randomization

ID	Title	Description
OG000	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.
OG001	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

Units

Secondary

Recurrent Venous Thromboembolism

Symptomatic recurrent venous thromboembolism (DVT and/or PE)

Modified full analysis set; intention to treat

Posted

Count of Participants

Participants

Within 24 months after randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Death

All-cause mortality

Modified full analysis set; intention to treat

Posted

Count of Participants

Participants

Within 10 days after randomization

ID	Title	Description
OG000	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.
OG001	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

Units

Secondary

Death

All-cause mortality

Modified full analysis set; intention to treat

Posted

Count of Participants

Participants

Within 24 months after randomization

ID	Title	Description
OG000	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.
OG001	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

Units

Secondary

Severity of Post-thrombotic Syndrome (Villalta)

Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

points

At 6 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Severity of Post-thrombotic Syndrome (Villalta)

Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

points

At 12 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Severity of Post-thrombotic Syndrome (Villalta)

Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

points

At 18 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Severity of Post-thrombotic Syndrome (Villalta)

Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

points

At 24 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Venous Clinical Severity Score

Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

points

At 6 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Venous Clinical Severity Score

Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

points

At 12 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Venous Clinical Severity Score

Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

points

At 18 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Venous Clinical Severity Score

Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

points

At 24 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Change in General Quality of Life - Physical

Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

units on a scale

Baseline to 24 months post-randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Change in General Quality of Life - Mental

Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.

Posted

Mean

Standard Error

units on a scale

Baseline to 24 months post-randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Change in Venous Disease-specific Quality of Life

Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

units on a scale

Baseline to 24 months post-randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Change in Leg Pain Severity

Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

points

Baseline to 10 days post-randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Change in Leg Pain Severity

Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

points

Baseline to 30 days post-randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Change in Leg Circumference

Mean calf circumference measured 10 cm below the tibial tuberosity

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

centimeters

Baseline to 10 days post-randomization

ID	Title	Description
OG000	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.
OG001	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

Secondary

Change in Leg Circumference

Mean calf circumference measured 10 cm below the tibial tuberosity

Modified full analysis set; intention to treat

Posted

Mean

Standard Error

centimeters

Baseline to 30 days post-randomization

ID	Title	Description
OG000	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.
OG001	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

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0006 events4 affected336 at risk EG0014 events4 affected355 at risk
Abnormal lab results secondary to undetermined infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Acute and progressive cauda equina syndrome	Nervous system disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Acute arterial limb ischemia of left lower extremity	Vascular disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Acute CHF with atrial fibrillation and rapid ventricular response	Cardiac disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Acute coronary syndrome	Cardiac disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Acute costochondritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Acute diverticulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events1 affected355 at risk
Acute encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Acute gallstone pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events1 affected355 at risk
Acute on chronic pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Acute on chronic respiratory insufficiency	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Acute oxycodone and doxylamine intoxication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Acute phencyclidine intoxication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Acute rejection (heart transplant)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Acute renal failure	Renal and urinary disorders	Systematic Assessment	EG0007 events5 affected336 at risk EG0014 events1 affected355 at risk
Acute right lower extremity DVT and acute bronchitis	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Acute short bowel obstruction versus Crohn's disease	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Acute thrombocytopenic purpura	Immune system disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Acute viral gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Adenocarcinoma of unknown primary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Alcohol intoxication	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events2 affected336 at risk EG0013 events3 affected355 at risk
Alcohol Withdrawal	Psychiatric disorders	Systematic Assessment	EG0004 events3 affected336 at risk EG0010 events0 affected355 at risk
Altered mental state	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Anemia	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected336 at risk EG0010 events0 affected355 at risk
Angioedema, unclear etiology	Immune system disorders	Systematic Assessment	EG0003 events1 affected336 at risk EG0010 events0 affected355 at risk
Antral gastritic	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Aortic insufficiency	Cardiac disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Arterial occlusion	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Aspiration pneumonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Asthma exacerbation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0011 events1 affected355 at risk
Asystole	Cardiac disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG00019 events3 affected336 at risk EG0015 events4 affected355 at risk
Atrial flutter with rapid ventricular response	Cardiac disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Atypical chest pain	Cardiac disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0012 events2 affected355 at risk
Back spasm	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Bacteremia	Infections and infestations	Systematic Assessment	EG0001 events1 affected336 at risk EG0011 events1 affected355 at risk
Bilateral lower extremity cellulitis and CHF	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Biliary diskinesia and sludge	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Bipolar disorder	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Bleeding at sheath puncture site	Vascular disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Bleeding from wound	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Bleeding gums	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Blurred vision and diffuse itching	Nervous system disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Breast intraductal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Broken ribs	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0013 events1 affected355 at risk
C5 on C6 retrolisthesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0003 events3 affected336 at risk EG0010 events0 affected355 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0007 events6 affected336 at risk EG0014 events4 affected355 at risk
Chest pain	General disorders	Systematic Assessment	EG0007 events7 affected336 at risk EG00111 events10 affected355 at risk
Chest pain/asthma exacerbation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events1 affected355 at risk
Chest pain and shortness of breath	Cardiac disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0013 events3 affected355 at risk
Chest pain, shortness of breath, hemoptysis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Cholangitis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0012 events2 affected355 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected336 at risk EG0018 events5 affected355 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0003 events1 affected336 at risk EG0011 events1 affected355 at risk
Colon cancer - adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Complex gouty septic olecranon bursitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Congestive heart failure	Cardiac disorders	Systematic Assessment	EG0004 events4 affected336 at risk EG0016 events2 affected355 at risk
Coronary artery disease	Cardiac disorders	Systematic Assessment	EG0003 events3 affected336 at risk EG0010 events0 affected355 at risk
Coronary artery disease and hypertension	Cardiac disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Death secondary to metastatic gastric carcinoma	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Debridement of right below-the-knee amputation	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Degenerative joint disease with total right hip replacement	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events2 affected355 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0013 events3 affected355 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Diabetic nephropathy	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Diabetic neuropathy	Endocrine disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0012 events2 affected355 at risk
Disconnected VP shunt	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Diverticulosis	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected336 at risk EG0010 events0 affected355 at risk
DVT and PE	Vascular disorders	Systematic Assessment	EG0003 events3 affected336 at risk EG0012 events2 affected355 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Dyspnea with lower extremity edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Elevated INR	Investigations	Systematic Assessment	EG0001 events1 affected336 at risk EG0012 events2 affected355 at risk
Elevated troponin	Investigations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Esophageal stricture	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Fall after alcohol abuse	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Fever	General disorders	Systematic Assessment	EG0002 events2 affected336 at risk EG0010 events0 affected355 at risk
Fibula fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected336 at risk EG0011 events1 affected355 at risk
Foot pain/burning	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0011 events1 affected355 at risk
Fracture and cellulitis of right first toe	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Fractured humerus and ribs - fell off ladder	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Gangrene left hallux	Infections and infestations	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Gastric adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Gastrointestinal bleed	Gastrointestinal disorders	Systematic Assessment	EG0008 events8 affected336 at risk EG0016 events6 affected355 at risk
Gastroparesis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Gunshot wound	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected336 at risk EG0012 events2 affected355 at risk
Hemoperitoneum of unknown etiology	Vascular disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Hemorrhagic cystitis	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Hemorrhagic shock	Vascular disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Heparin induced thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected336 at risk EG0010 events0 affected355 at risk
Herniated lumbar disc	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0011 events1 affected355 at risk
Hip fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events2 affected355 at risk
Hypertensive urgency	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Hypertensive urgency with CHF exacerbation	Cardiac disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Hyperthyroidism	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Hypovolemic shocck	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Hypoxia due to hypoventilation due to multiple pain medications	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Influenza A	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Intertigo labialis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Intra-abdominal fluid collection secondary to bile leak	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Intra-abdominal infection	Infections and infestations	Systematic Assessment	EG0002 events1 affected336 at risk EG0010 events0 affected355 at risk
Intracranial hemorrhage	Nervous system disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Irritable bowel syndrome	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Kidney cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Lactic acidosis, acute sepsis, atrial fibrillation	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Left C4-C5 neuroforaminal stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Left hip removal of hardware and total hip arthoplasty	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Left lower extremity pain and abscess	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Leg pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected336 at risk EG0013 events3 affected355 at risk
Leg pain and swelling	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events1 affected355 at risk
Leg swelling	Cardiac disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0011 events1 affected355 at risk
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Lightheadedness	Cardiac disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Low hemoglobin	Investigations	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events1 affected355 at risk
Mania, bizarre behavior, agitation	Investigations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Massive closed head injury	Nervous system disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Mediastinal adenopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Metastatic adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Metastatic lung cancer	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events1 affected355 at risk
Migrated VP shunt	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events1 affected355 at risk
Motor vehicle accident	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Methicillin-resistant Staphylococcus Aureus - wound	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Multisystem organ failure	General disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Nausea and vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Nausea, vomiting, diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected336 at risk EG0010 events0 affected355 at risk
Non-ST wave myocardial infarction	Cardiac disorders	Systematic Assessment	EG0005 events3 affected336 at risk EG0010 events0 affected355 at risk
Obstipation with ileus	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Obstructing ureteral stone	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Orthostatic hyptension secondary to beta blockers and dehydration	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Osteomyelitis	Infections and infestations	Systematic Assessment	EG0002 events2 affected336 at risk EG0010 events0 affected355 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Overdose	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Pancreatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events1 affected355 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Perihepatic abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Peripheral arterial disease	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events1 affected336 at risk EG0010 events0 affected355 at risk
Pleuritic chest pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0011 events1 affected355 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0005 events3 affected336 at risk EG0016 events6 affected355 at risk
Pneumonia and pulmonary hypertension likely due to PE	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Post-operative infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Post-percardiotomy syndrome	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events1 affected336 at risk EG0010 events0 affected355 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected336 at risk EG0010 events0 affected355 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00012 events10 affected336 at risk EG0019 events7 affected355 at risk
Pyelonephritis	Infections and infestations	Systematic Assessment	EG0001 events1 affected336 at risk EG0011 events1 affected355 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG00036 events25 affected336 at risk EG00120 events17 affected355 at risk
Renal vein obstruction	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Reversible cerebral vasoconstriction syndrome	Nervous system disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Right foot amputation	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Right hand abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Right knee hematoma	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Right knee tear of medial meniscus	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Ruptured ovarian cyst	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Sarcoidosis	Immune system disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Seizure	Nervous system disorders	Systematic Assessment	EG0003 events3 affected336 at risk EG0011 events1 affected355 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0016 events5 affected355 at risk
Sepsis and pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Septic shock	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events2 affected355 at risk
Serum sickness	Immune system disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Severe bilateral knee degenerative joint disease	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Short-term memory impairment of uncertain etiology	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0002 events2 affected336 at risk EG0010 events0 affected355 at risk
Small bowel obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0011 events1 affected355 at risk
Spinal headache	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Squamous cell carcinoma of unknown primary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Staph infection in right shoulder	Infections and infestations	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Stroke	Nervous system disorders	Systematic Assessment	EG0006 events6 affected336 at risk EG0010 events0 affected355 at risk
Subdural hematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected336 at risk EG0010 events0 affected355 at risk
Suicidal ideation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0016 events1 affected355 at risk
Suicidal ideation and alcohol withdrawal	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events1 affected355 at risk
Suicide attempt	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Surgical excision of squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Suspected infection to stump from right below-knee amputation	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0016 events5 affected355 at risk
Syncope and head contusion	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Transient dysarthria	Nervous system disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Transient ischemia attack	Nervous system disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Type A ascending aortic dissection	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Urinary tract infection	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0011 events1 affected355 at risk
Urinary tract infection and cellulitis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Uterine bleeding	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0012 events2 affected355 at risk
Uterine cancer	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Vaginal bleeding	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Ventricular perforation	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Viral gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Viral syndrome	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Vomoting and diarrhea	Infections and infestations	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Venous thromboembolism	Vascular disorders	Systematic Assessment	EG0000 events0 affected336 at risk EG0011 events1 affected355 at risk
Wound abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected336 at risk EG0010 events0 affected355 at risk
Retroperitoneal bleed	Vascular disorders	Systematic Assessment	EG0002 events2 affected336 at risk EG0011 events1 affected355 at risk

ID	Term
D020246	Venous Thrombosis
D011186	Postphlebitic Syndrome
D054556	Venous Thromboembolism
D054070	Postthrombotic Syndrome
D013927	Thrombosis

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010689	Phlebitis
D016491	Peripheral Vascular Diseases
D014689	Venous Insufficiency
D013923	Thromboembolism

ID	Term
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D057057	Serine Proteases
D010960	Plasminogen Activators
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D001685	Biological Factors

ID	Title	Description
BG000	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.
BG001	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
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	336	109	336	0	336
EG001	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	355	86	355	0	355