Trial Outcomes & Findings for Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (NCT NCT00790335)

NCT ID: NCT00790335

Last Updated: 2018-03-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 692 participants
• Primary outcome timeframe: Between 6 and 24 months after randomization
• Results posted on: 2018-03-29

Participant Flow

Participant milestones

Measure	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.	B-Control 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 \[INR} 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Study STARTED	337	355
Overall Study COMPLETED	257	243
Overall Study NOT COMPLETED	80	112

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis

Baseline characteristics by cohort

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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	Total n=691 Participants Total of all reporting groups
Age, Continuous	52 years n=5 Participants	53 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	131 Participants n=5 Participants	134 Participants n=7 Participants	265 Participants n=5 Participants
Sex: Female, Male Male	205 Participants n=5 Participants	221 Participants n=7 Participants	426 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	26 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	310 Participants n=5 Participants	319 Participants n=7 Participants	629 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	61 Participants n=5 Participants	62 Participants n=7 Participants	123 Participants n=5 Participants
Race (NIH/OMB) White	265 Participants n=5 Participants	276 Participants n=7 Participants	541 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Body-mass index	31 kilograms per square meter n=5 Participants	30 kilograms per square meter n=7 Participants	31 kilograms per square meter n=5 Participants
Symptom severity score None or very mild (0-4)	57 Participants n=5 Participants	69 Participants n=7 Participants	126 Participants n=5 Participants
Symptom severity score Mild (5-9)	115 Participants n=5 Participants	124 Participants n=7 Participants	239 Participants n=5 Participants
Symptom severity score Moderate (10-14)	98 Participants n=5 Participants	94 Participants n=7 Participants	192 Participants n=5 Participants
Symptom severity score Severe (> 14)	66 Participants n=5 Participants	66 Participants n=7 Participants	132 Participants n=5 Participants
Symptom severity score Not documented	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Side of index DVT Left leg	207 Participants n=5 Participants	218 Participants n=7 Participants	425 Participants n=5 Participants
Side of index DVT Right leg	129 Participants n=5 Participants	137 Participants n=7 Participants	266 Participants n=5 Participants
Previous DVT or PE	83 Participants n=5 Participants	87 Participants n=7 Participants	170 Participants n=5 Participants
Previous ipsilateral DVT	5 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants
DVT extends into iliac or common femoral vein	195 Participants n=5 Participants	196 Participants n=7 Participants	391 Participants n=5 Participants
DVT risk factors Major surgery	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants
DVT risk factors Hospitalization	26 Participants n=5 Participants	38 Participants n=7 Participants	64 Participants n=5 Participants
DVT risk factors Plaster cast immobilization	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
DVT risk factors Childbirth	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
DVT risk factors None of the above risk factors	272 Participants n=5 Participants	269 Participants n=7 Participants	541 Participants n=5 Participants
Outpatient	268 Participants n=5 Participants	300 Participants n=7 Participants	568 Participants n=5 Participants
Time from symptom start to randomization	6 days n=5 Participants	6 days n=7 Participants	6 days n=5 Participants
Aspirin use within past 7 days	68 Participants n=5 Participants	74 Participants n=7 Participants	142 Participants n=5 Participants
Estimated glomerular filtration rate	86 milliliters per minute n=5 Participants	86 milliliters per minute n=7 Participants	86 milliliters per minute n=5 Participants
Hypertension	143 Participants n=5 Participants	139 Participants n=7 Participants	282 Participants n=5 Participants
Diabetes	59 Participants n=5 Participants	54 Participants n=7 Participants	113 Participants n=5 Participants
High cholesterol	97 Participants n=5 Participants	105 Participants n=7 Participants	202 Participants n=5 Participants
Asthma	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Chronic obstructive pulmonary disease	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Angina or myocardial infarction	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Congestive heart failure	13 Participants n=5 Participants	19 Participants n=7 Participants	32 Participants n=5 Participants
Height	174 centimeters STANDARD_DEVIATION 11 • n=5 Participants	174 centimeters STANDARD_DEVIATION 10 • n=7 Participants	174 centimeters STANDARD_DEVIATION 11 • n=5 Participants
Weight	97 kilograms STANDARD_DEVIATION 25 • n=5 Participants	96 kilograms STANDARD_DEVIATION 24 • n=7 Participants	97 kilograms STANDARD_DEVIATION 24 • n=5 Participants

PRIMARY outcome

Timeframe: Between 6 and 24 months after randomization

Population: Modified full analysis set; intention-to-treat

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.

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)	157 Participants	171 Participants

SECONDARY outcome

Timeframe: Through 24 months

Population: Modified full analysis set; intention to treat

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.

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Major Non-post-thrombotic Syndrome Treatment Failure	4 Participants	7 Participants

SECONDARY outcome

Timeframe: Through 24 months

Population: Modified full analysis set; intention to treat

Composite of PTS and major non-PTS treatment failure

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Any Treatment Failure	158 Participants	176 Participants

SECONDARY outcome

Timeframe: Between 6 and 24 months after randomization

Population: Modified full analysis set, intention-to-treat

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.

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Moderate-to-severe Post-thrombotic Syndrome	60 Participants	84 Participants

SECONDARY outcome

Timeframe: Within 10 days after randomization

Population: Modified full analysis set, intention-to-treat

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).

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Major Bleeding	6 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 24 months after randomization

Population: Modified full analysis set; intention-to-treat

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).

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Major Bleeding	19 Participants	13 Participants

SECONDARY outcome

Timeframe: Within 10 days after randomization

Population: Modified full analysis set, intention-to-treat

Clinically overt bleeding that occurred through 10 days post-randomization

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Any (Minor + Major) Bleeding	15 Participants	6 Participants

SECONDARY outcome

Timeframe: Within 24 months after randomization

Population: Modified full analysis set, intention-to-treat

Clinically overt bleeding that occurred within 24 months post-randomization

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Any (Major + Minor) Bleeding	46 Participants	38 Participants

SECONDARY outcome

Timeframe: Within 10 days after randomization

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

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Recurrent Venous Thromboembolism	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Within 24 months after randomization

Population: Modified full analysis set; intention to treat

Symptomatic recurrent venous thromboembolism (DVT and/or PE)

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Recurrent Venous Thromboembolism	42 Participants	30 Participants

SECONDARY outcome

Timeframe: Within 10 days after randomization

Population: Modified full analysis set; intention to treat

All-cause mortality

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 24 months after randomization

Population: Modified full analysis set; intention to treat

All-cause mortality

Outcome measures

Measure	A-Intervention n=336 Participants 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.	B-Control n=355 Participants 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
Death	7 Participants	8 Participants

SECONDARY outcome

Timeframe: At 6 months

Population: Modified full analysis set; intention to treat

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

Outcome measures

Measure	A-Intervention n=291 Participants 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.	B-Control n=285 Participants 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
Severity of Post-thrombotic Syndrome (Villalta)	3.11 points Standard Error 0.24	4.33 points Standard Error 0.24

SECONDARY outcome

Timeframe: At 12 months

Population: Modified full analysis set; intention to treat

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

Outcome measures

Measure	A-Intervention n=272 Participants 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.	B-Control n=258 Participants 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
Severity of Post-thrombotic Syndrome (Villalta)	3.22 points Standard Error 0.22	4.38 points Standard Error 0.22

SECONDARY outcome

Timeframe: At 18 months

Population: Modified full analysis set; intention to treat

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

Outcome measures

Measure	A-Intervention n=245 Participants 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.	B-Control n=222 Participants 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
Severity of Post-thrombotic Syndrome (Villalta)	3.32 points Standard Error 0.24	4.44 points Standard Error 0.24

SECONDARY outcome

Timeframe: At 24 months

Population: Modified full analysis set; intention to treat

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

Outcome measures

Measure	A-Intervention n=258 Participants 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.	B-Control n=239 Participants 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
Severity of Post-thrombotic Syndrome (Villalta)	3.43 points Standard Error 0.28	4.50 points Standard Error 0.29

SECONDARY outcome

Timeframe: At 6 months

Population: Modified full analysis set; intention to treat

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

Outcome measures

Measure	A-Intervention n=289 Participants 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.	B-Control n=279 Participants 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
Venous Clinical Severity Score	1.73 points Standard Error 0.15	2.68 points Standard Error 0.15

SECONDARY outcome

Timeframe: At 12 months

Population: Modified full analysis set; intention to treat

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

Outcome measures

Measure	A-Intervention n=265 Participants 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.	B-Control n=253 Participants 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
Venous Clinical Severity Score	1.80 points Standard Error 0.16	2.37 points Standard Error 0.16

SECONDARY outcome

Timeframe: At 18 months

Population: Modified full analysis set; intention to treat

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

Outcome measures

Measure	A-Intervention n=240 Participants 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.	B-Control n=215 Participants 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
Venous Clinical Severity Score	1.74 points Standard Error 0.17	2.80 points Standard Error 0.18

SECONDARY outcome

Timeframe: At 24 months

Population: Modified full analysis set; intention to treat

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

Outcome measures

Measure	A-Intervention n=235 Participants 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.	B-Control n=214 Participants 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
Venous Clinical Severity Score	1.87 points Standard Error 0.18	2.42 points Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline to 24 months post-randomization

Population: Modified full analysis set; intention to treat

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.

Outcome measures

Measure	A-Intervention n=245 Participants 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.	B-Control n=222 Participants 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
Change in General Quality of Life - Physical	11.18 units on a scale Standard Error 0.91	10.06 units on a scale Standard Error 2.70

SECONDARY outcome

Timeframe: Baseline to 24 months post-randomization

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.

Outcome measures

Measure	A-Intervention n=245 Participants 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.	B-Control n=222 Participants 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
Change in General Quality of Life - Mental	2.70 units on a scale Standard Error 0.84	2.70 units on a scale Standard Error 0.89

SECONDARY outcome

Timeframe: Baseline to 24 months post-randomization

Population: Modified full analysis set; intention to treat

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.

Outcome measures

Measure	A-Intervention n=249 Participants 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.	B-Control n=226 Participants 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
Change in Venous Disease-specific Quality of Life	27.67 units on a scale Standard Error 1.71	23.47 units on a scale Standard Error 17.31

SECONDARY outcome

Timeframe: Baseline to 10 days post-randomization

Population: Modified full analysis set; intention to treat

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

Outcome measures

Measure	A-Intervention n=317 Participants 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.	B-Control n=325 Participants 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
Change in Leg Pain Severity	-1.62 points Standard Error 0.10	-1.29 points Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline to 30 days post-randomization

Population: Modified full analysis set; intention to treat

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

Outcome measures

Measure	A-Intervention n=314 Participants 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.	B-Control n=317 Participants 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
Change in Leg Pain Severity	-2.17 points Standard Error 0.11	-1.83 points Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline to 10 days post-randomization

Population: Modified full analysis set; intention to treat

Mean calf circumference measured 10 cm below the tibial tuberosity

Outcome measures

Measure	A-Intervention n=305 Participants 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.	B-Control n=323 Participants 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
Change in Leg Circumference	-0.26 centimeters Standard Error 0.17	0.27 centimeters Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline to 30 days post-randomization

Population: Modified full analysis set; intention to treat

Mean calf circumference measured 10 cm below the tibial tuberosity

Outcome measures

Measure	A-Intervention n=304 Participants 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.	B-Control n=315 Participants 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
Change in Leg Circumference	-0.74 centimeters Standard Error 0.17	-0.28 centimeters Standard Error 0.16

Adverse Events

A-Intervention

Serious events: 109 serious events

Other events: 0 other events

Deaths: 7 deaths

B-Control

Serious events: 86 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Measure	A-Intervention n=336 participants at risk 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.	B-Control n=355 participants at risk 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
Gastrointestinal disorders Abdominal pain	1.2% 4/336 • Number of events 6 • 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.	1.1% 4/355 • Number of events 4 • 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.
Infections and infestations Abnormal lab results secondary to undetermined infection	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Nervous system disorders Acute and progressive cauda equina syndrome	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Vascular disorders Acute arterial limb ischemia of left lower extremity	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Cardiac disorders Acute CHF with atrial fibrillation and rapid ventricular response	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Cardiac disorders Acute coronary syndrome	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Musculoskeletal and connective tissue disorders Acute costochondritis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Acute diverticulitis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 2 • 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.
Nervous system disorders Acute encephalopathy	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Gastrointestinal disorders Acute gallstone pancreatitis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 2 • 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.
Gastrointestinal disorders Acute on chronic pancreatitis	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Respiratory, thoracic and mediastinal disorders Acute on chronic respiratory insufficiency	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Injury, poisoning and procedural complications Acute oxycodone and doxylamine intoxication	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Injury, poisoning and procedural complications Acute phencyclidine intoxication	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Cardiac disorders Acute rejection (heart transplant)	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Renal and urinary disorders Acute renal failure	1.5% 5/336 • Number of events 7 • 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.	0.28% 1/355 • Number of events 4 • 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.
Vascular disorders Acute right lower extremity DVT and acute bronchitis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Gastrointestinal disorders Acute short bowel obstruction versus Crohn's disease	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Immune system disorders Acute thrombocytopenic purpura	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Acute viral gastroenteritis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of unknown primary	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Injury, poisoning and procedural complications Alcohol intoxication	0.60% 2/336 • Number of events 3 • 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.	0.85% 3/355 • Number of events 3 • 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.
Psychiatric disorders Alcohol Withdrawal	0.89% 3/336 • Number of events 4 • 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.	0.00% 0/355 • 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.
Psychiatric disorders Altered mental state	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Gastrointestinal disorders Anemia	0.60% 2/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Immune system disorders Angioedema, unclear etiology	0.30% 1/336 • Number of events 3 • 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.	0.00% 0/355 • 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.
Gastrointestinal disorders Antral gastritic	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Cardiac disorders Aortic insufficiency	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Cardiac disorders Arrhythmia	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Vascular disorders Arterial occlusion	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Respiratory, thoracic and mediastinal disorders Asthma exacerbation	0.30% 1/336 • Number of events 1 • 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.	0.28% 1/355 • Number of events 1 • 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.
Cardiac disorders Asystole	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Cardiac disorders Atrial fibrillation	0.89% 3/336 • Number of events 19 • 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.	1.1% 4/355 • Number of events 5 • 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.
Cardiac disorders Atrial flutter with rapid ventricular response	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Cardiac disorders Atypical chest pain	0.30% 1/336 • Number of events 1 • 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.	0.56% 2/355 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Back spasm	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Bacteremia	0.30% 1/336 • Number of events 1 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Bilateral lower extremity cellulitis and CHF	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Hepatobiliary disorders Biliary diskinesia and sludge	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Psychiatric disorders Bipolar disorder	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Vascular disorders Bleeding at sheath puncture site	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Vascular disorders Bleeding from wound	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Gastrointestinal disorders Bleeding gums	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Nervous system disorders Blurred vision and diffuse itching	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast intraductal papilloma	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Injury, poisoning and procedural complications Broken ribs	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 3 • 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.
Nervous system disorders C5 on C6 retrolisthesia	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Cardiac disorders Cardiomyopathy	0.89% 3/336 • Number of events 3 • 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.	0.00% 0/355 • 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.
Infections and infestations Cellulitis	1.8% 6/336 • Number of events 7 • 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.	1.1% 4/355 • Number of events 4 • 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.
General disorders Chest pain	2.1% 7/336 • Number of events 7 • 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.	2.8% 10/355 • Number of events 11 • 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.
Respiratory, thoracic and mediastinal disorders Chest pain/asthma exacerbation	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 2 • 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.
Cardiac disorders Chest pain and shortness of breath	0.00% 0/336 • 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.	0.85% 3/355 • Number of events 3 • 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.
Cardiac disorders Chest pain, shortness of breath, hemoptysis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Hepatobiliary disorders Cholangitis	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Hepatobiliary disorders Cholecystitis	0.30% 1/336 • Number of events 1 • 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.	0.56% 2/355 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.89% 3/336 • Number of events 3 • 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.	1.4% 5/355 • Number of events 8 • 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.
Gastrointestinal disorders Colitis	0.30% 1/336 • Number of events 3 • 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.	0.28% 1/355 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer - adenocarcinoma	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Complex gouty septic olecranon bursitis	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Cardiac disorders Congestive heart failure	1.2% 4/336 • Number of events 4 • 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.	0.56% 2/355 • Number of events 6 • 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.
Cardiac disorders Coronary artery disease	0.89% 3/336 • Number of events 3 • 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.	0.00% 0/355 • 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.
Cardiac disorders Coronary artery disease and hypertension	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Gastrointestinal disorders Death secondary to metastatic gastric carcinoma	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Surgical and medical procedures Debridement of right below-the-knee amputation	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Surgical and medical procedures Degenerative joint disease with total right hip replacement	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Metabolism and nutrition disorders Dehydration	0.00% 0/336 • 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.	0.56% 2/355 • Number of events 2 • 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.
Psychiatric disorders Depression	0.30% 1/336 • Number of events 1 • 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.	0.85% 3/355 • Number of events 3 • 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.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Endocrine disorders Diabetic neuropathy	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Gastrointestinal disorders Diarrhea	0.30% 1/336 • Number of events 1 • 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.	0.56% 2/355 • Number of events 2 • 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.
Injury, poisoning and procedural complications Disconnected VP shunt	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Gastrointestinal disorders Diverticulosis	0.60% 2/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Vascular disorders DVT and PE	0.89% 3/336 • Number of events 3 • 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.	0.56% 2/355 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea with lower extremity edema	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Investigations Elevated INR	0.30% 1/336 • Number of events 1 • 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.	0.56% 2/355 • Number of events 2 • 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.
Investigations Elevated troponin	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Gastrointestinal disorders Esophageal stricture	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Injury, poisoning and procedural complications Fall after alcohol abuse	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
General disorders Fever	0.60% 2/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Injury, poisoning and procedural complications Fibula fracture	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Musculoskeletal and connective tissue disorders Flank pain	0.60% 2/336 • Number of events 2 • 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.	0.28% 1/355 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Foot pain/burning	0.30% 1/336 • Number of events 1 • 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.	0.28% 1/355 • Number of events 1 • 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.
Injury, poisoning and procedural complications Fracture and cellulitis of right first toe	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Injury, poisoning and procedural complications Fractured humerus and ribs - fell off ladder	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Gangrene left hallux	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenocarcinoma	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Gastrointestinal disorders Gastrointestinal bleed	2.4% 8/336 • Number of events 8 • 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.	1.7% 6/355 • Number of events 6 • 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.
Gastrointestinal disorders Gastroparesis	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Injury, poisoning and procedural complications Gunshot wound	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Renal and urinary disorders Hematuria	0.60% 2/336 • Number of events 2 • 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.	0.56% 2/355 • Number of events 2 • 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.
Vascular disorders Hemoperitoneum of unknown etiology	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Renal and urinary disorders Hemorrhagic cystitis	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Vascular disorders Hemorrhagic shock	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Blood and lymphatic system disorders Heparin induced thrombocytopenia	0.89% 3/336 • Number of events 3 • 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.	0.00% 0/355 • 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.
Musculoskeletal and connective tissue disorders Herniated lumbar disc	0.30% 1/336 • Number of events 1 • 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.	0.28% 1/355 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Hip fracture	0.00% 0/336 • 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.	0.56% 2/355 • Number of events 2 • 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.
Vascular disorders Hypertensive urgency	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Cardiac disorders Hypertensive urgency with CHF exacerbation	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Metabolism and nutrition disorders Hyperthyroidism	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Metabolism and nutrition disorders Hypoglycemia	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Vascular disorders Hypovolemic shocck	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Hypoxia due to hypoventilation due to multiple pain medications	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Infections and infestations Influenza A	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Intertigo labialis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Gastrointestinal disorders Intra-abdominal fluid collection	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Injury, poisoning and procedural complications Intra-abdominal fluid collection secondary to bile leak	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Infections and infestations Intra-abdominal infection	0.30% 1/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Nervous system disorders Intracranial hemorrhage	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kidney cancer	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Metabolism and nutrition disorders Lactic acidosis, acute sepsis, atrial fibrillation	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Musculoskeletal and connective tissue disorders Left C4-C5 neuroforaminal stenosis	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Surgical and medical procedures Left hip removal of hardware and total hip arthoplasty	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Musculoskeletal and connective tissue disorders Left lower extremity pain and abscess	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Leg pain	0.60% 2/336 • Number of events 2 • 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.	0.85% 3/355 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders Leg pain and swelling	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 2 • 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.
Cardiac disorders Leg swelling	0.30% 1/336 • Number of events 1 • 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.	0.28% 1/355 • Number of events 1 • 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.
Blood and lymphatic system disorders Leukocytosis	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Cardiac disorders Lightheadedness	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Investigations Low hemoglobin	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 2 • 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.
Investigations Mania, bizarre behavior, agitation	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Nervous system disorders Massive closed head injury	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Blood and lymphatic system disorders Mediastinal adenopathy	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic adenocarcinoma	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Metastatic lung cancer	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 2 • 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.
Injury, poisoning and procedural complications Migrated VP shunt	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 2 • 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.
Injury, poisoning and procedural complications Motor vehicle accident	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Injury, poisoning and procedural complications Methicillin-resistant Staphylococcus Aureus - wound	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
General disorders Multisystem organ failure	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Gastrointestinal disorders Nausea and vomiting	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Gastrointestinal disorders Nausea, vomiting, diarrhea	0.60% 2/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Cardiac disorders Non-ST wave myocardial infarction	0.89% 3/336 • Number of events 5 • 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.	0.00% 0/355 • 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.
Gastrointestinal disorders Obstipation with ileus	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Renal and urinary disorders Obstructing ureteral stone	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Vascular disorders Orthostatic hyptension secondary to beta blockers and dehydration	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Osteomyelitis	0.60% 2/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Injury, poisoning and procedural complications Overdose	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic cancer	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 2 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Perihepatic abscess	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Vascular disorders Peripheral arterial disease	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.30% 1/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Respiratory, thoracic and mediastinal disorders Pleuritic chest pain	0.30% 1/336 • Number of events 1 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Pneumonia	0.89% 3/336 • Number of events 5 • 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.	1.7% 6/355 • Number of events 6 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia and pulmonary hypertension likely due to PE	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Infections and infestations Post-operative infection	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Injury, poisoning and procedural complications Post-percardiotomy syndrome	0.30% 1/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.60% 2/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.0% 10/336 • Number of events 12 • 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.	2.0% 7/355 • Number of events 9 • 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.
Infections and infestations Pyelonephritis	0.30% 1/336 • Number of events 1 • 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.	0.28% 1/355 • Number of events 1 • 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.
Vascular disorders Deep vein thrombosis	7.4% 25/336 • Number of events 36 • 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.	4.8% 17/355 • Number of events 20 • 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.
Renal and urinary disorders Renal vein obstruction	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Nervous system disorders Reversible cerebral vasoconstriction syndrome	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Surgical and medical procedures Right foot amputation	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Infections and infestations Right hand abscess	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Vascular disorders Right knee hematoma	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Injury, poisoning and procedural complications Right knee tear of medial meniscus	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Reproductive system and breast disorders Ruptured ovarian cyst	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Immune system disorders Sarcoidosis	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Nervous system disorders Seizure	0.89% 3/336 • Number of events 3 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Sepsis	0.00% 0/336 • 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.	1.4% 5/355 • Number of events 6 • 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.
Infections and infestations Sepsis and pneumonia	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Septic shock	0.00% 0/336 • 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.	0.56% 2/355 • Number of events 2 • 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.
Immune system disorders Serum sickness	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Musculoskeletal and connective tissue disorders Severe bilateral knee degenerative joint disease	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Psychiatric disorders Short-term memory impairment of uncertain etiology	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Sinusitis	0.60% 2/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Gastrointestinal disorders Small bowel obstruction	0.30% 1/336 • Number of events 1 • 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.	0.28% 1/355 • Number of events 1 • 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.
Injury, poisoning and procedural complications Spinal headache	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of unknown primary	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Infections and infestations Staph infection in right shoulder	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Nervous system disorders Stroke	1.8% 6/336 • Number of events 6 • 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.	0.00% 0/355 • 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.
Injury, poisoning and procedural complications Subdural hematoma	0.60% 2/336 • Number of events 2 • 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.	0.00% 0/355 • 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.
Psychiatric disorders Suicidal ideation	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 6 • 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.
Psychiatric disorders Suicidal ideation and alcohol withdrawal	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 2 • 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.
Psychiatric disorders Suicide attempt	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Surgical excision of squamous cell carcinoma	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Infections and infestations Suspected infection to stump from right below-knee amputation	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Nervous system disorders Syncope	0.30% 1/336 • Number of events 1 • 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.	1.4% 5/355 • Number of events 6 • 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.
Vascular disorders Syncope and head contusion	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Nervous system disorders Transient dysarthria	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Nervous system disorders Transient ischemia attack	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Vascular disorders Type A ascending aortic dissection	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Renal and urinary disorders Urinary tract infection	0.30% 1/336 • Number of events 1 • 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.	0.28% 1/355 • Number of events 1 • 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.
Renal and urinary disorders Urinary tract infection and cellulitis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Reproductive system and breast disorders Uterine bleeding	0.00% 0/336 • 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.	0.56% 2/355 • Number of events 2 • 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.
Reproductive system and breast disorders Uterine cancer	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Reproductive system and breast disorders Vaginal bleeding	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Injury, poisoning and procedural complications Ventricular perforation	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Ear and labyrinth disorders Vertigo	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Viral gastroenteritis	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Viral syndrome	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Vomoting and diarrhea	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Vascular disorders Venous thromboembolism	0.00% 0/336 • 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.	0.28% 1/355 • Number of events 1 • 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.
Infections and infestations Wound abscess	0.30% 1/336 • Number of events 1 • 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.	0.00% 0/355 • 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.
Vascular disorders Retroperitoneal bleed	0.60% 2/336 • Number of events 2 • 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.	0.28% 1/355 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Suresh Vedantham, Principal Investigator

Washington University in St. Louis

Phone: 3143622900

Email: vedanthams@mir.wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place