The PEERLESS Study | NCT05111613

Label	Type	Description	Intervention Names
Randomized Controlled Trial Cohort - FlowTriever Arm	Active Comparator	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.	Device: FlowTriever System
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Active Comparator	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)	Device: Catheter-Directed Thrombolysis
Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Other	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.	Device: FlowTriever System

Name	Type	Description	Arm Group Labels	Other Names
Catheter-Directed Thrombolysis	Device	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm

Measure	Description	Time Frame
Primary Endpoint: Composite Clinical Endpoint Constructed as a 5-Component Win Ratio	The primary endpoint is a composite constructed as a hierarchical win ratio of the following 5 components: All-cause mortality, or Intracranial hemorrhage (ICH), or Major bleeding per ISTH definition, or Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure. A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.	Hospital discharge or at 7 days after the index procedure, whichever is sooner

Measure	Description	Time Frame
Composite Clinical Endpoint Constructed as a 4-Component Win Ratio	This secondary endpoint is a composite constructed as a hierarchical win ratio of the following 4 components: All-cause mortality, or Intracranial hemorrhage (ICH), or Major bleeding per ISTH definition, or Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.

Name	Affiliation	Role
Wissam Jaber, MD	Emory University	Principal Investigator
Carin Gonsalves, MD	Thomas Jefferson University	Principal Investigator
Stefan Stortecky, MD	Bern University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda University Health		Loma Linda	California	92354	United States
Providence St. Joseph Orange

PubMed Identifier	Type	Citation	Retractions
37703948	Background	Gonsalves CF, Gibson CM, Stortecky S, Alvarez RA, Beam DM, Horowitz JM, Silver MJ, Toma C, Rundback JH, Rosenberg SP, Markovitz CD, Tu T, Jaber WA. Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study. Am Heart J. 2023 Dec;266:128-137. doi: 10.1016/j.ahj.2023.09.002. Epub 2023 Sep 12.
39470698

ID	Title	Description
FG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
FG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 23, 2023	Apr 8, 2025

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002142 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
White	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Race/Ethnicity, Customized

Subject reported ethnicity was unavailable in 25 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 26 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 20 subjects in the non-randomized cohort.

Count of Participants

Participants

Title	Denominators	Categories
Hispanic or Latino	ParticipantsBG000249 ParticipantsBG001250 ParticipantsBG002

Body Mass Index

Data missing for one subject in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and one subject in the non-randomized cohort.

Mean

Standard Deviation

kg/m^2

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001275 ParticipantsBG002

History of cancer

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Active cancer

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Prior pulmonary embolism

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

History of pulmonary hypertension

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Prior deep vein thrombosis

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Concomitant deep vein thrombosis

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

History of bleeding

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Active bleeding preprocedure

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Anemia

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

History of renal disease

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Renal dysfunction (CrCL 30-60 mL/min)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Recent surgery (within 3 weeks)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Recent trauma (within 3 weeks)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Prior cerebrovascular accident

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Relative contraindication to thrombolytics

Categories are not mutually exclusive; 11 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm had a total of 12 relative contraindications.

Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.

Count of Participants

Participants

Title	Denominators	Categories
Total	ParticipantsBG000274 ParticipantsBG001276

Absolute contraindication to thrombolytics

Categories are not mutually exclusive.

Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.

Count of Participants

Participants

Title	Denominators	Categories
Total	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

VTE-BLEED score

The VTE-BLEED score is a clinical tool used to estimate the risk of bleeding in subjects receiving long-term anticoagulation treatment for venous thromboembolism (VTE). It helps clinicians identify individuals who may be at increased risk of bleeding and can aid in making informed decisions about anticoagulation strategies. Scores range from 0 to 9. A low score (typically <2) suggests a lower risk of bleeding, while a higher score indicates a greater risk of bleeding.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276

VTE-BLEED score

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

sPESI score

The simplified Pulmonary Embolism Severity Index (sPESI) score is a tool used to classify the risk of death and complications in subjects with pulmonary embolism (PE). The scale ranges from 0 to 6, with higher values indicating increased risk of death and complications.

Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG000273 ParticipantsBG001276

sPESI score

Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000273 ParticipantsBG001276 ParticipantsBG002

Intermediate risk PE

All enrolled subjects were required by protocol to have intermediate-risk PE per European Society of Cardiology (ESC) guidelines (hemodynamic stability and RV dilatation on imaging), and subjects enrolled before protocol version 3.0 were required to have elevated cardiac troponin levels (intermediate-high-risk PE per ESC criteria).

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Duration of symptoms, days

Mean

Standard Deviation

days

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Elevated cardiac troponin levels

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Most central PE location at screening

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Right bundle branch block

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Heart rate, bpm

Mean

Standard Deviation

beats per minute

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Respiratory rate, rpm

Data unavailable for 1 subject in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 1 subject in the non-randomized cohort.

Mean

Standard Deviation

respirations per minute

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001275 ParticipantsBG002

Systolic blood pressure at diagnosis, mmHg

Data unavailable for 1 subject in the non-randomized cohort.

Mean

Standard Deviation

mmHg

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Diastolic blood pressure at diagnosis, mmHg

Data unavailable for 1 subject in the non-randomized cohort.

Mean

Standard Deviation

mmHg

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

mMRC dyspnea score

The mMRC scale (modified Medical Research Council) is a subject-reported outcome tool used to assess the impact of breathlessness (dyspnea) on daily activities. It is a self-assessment scale ranging from 0 to 4, where higher scores indicate greater breathlessness.

Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000271 ParticipantsBG001

NYHA classification

The NYHA (New York Heart Association) classification is a system that categorizes heart failure symptoms based on severity and physical activity limitations. The scale ranges from I to IV, with higher values denoting worse functional capacity and symptoms.

Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000272 ParticipantsBG001

Modified Borg dyspnea score

The Modified Borg dyspnea score is a tool used to measure and quantify the perceived difficulty of breathing during exercise. It is a numerical scale ranging from 0 (no difficulty) to 10 (maximal difficulty).

Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 7 subjects in the non-randomized cohort.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001274

RV/LV ratio (CTPA or echocardiogram)

The RV/LV ratio, or right ventricle to left ventricle ratio, is a measurement of the ratio of the right ventricular diameter to the left ventricular diameter. An elevated RV/LV ratio can suggest that the right ventricle is enlarged, which can be a sign of increased pressure or workload on the right heart, and can be an independent predictor of adverse outcomes, such as mortality, in patients with PE.

Data unavailable for 12 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 16 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 14 subjects in the non-randomized cohort.

Mean

Standard Deviation

ratio

Title	Denominators	Categories
	ParticipantsBG000262 ParticipantsBG001

RV function on echocardiogram

Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000178 ParticipantsBG001171 ParticipantsBG002

Parenteral anticoagulation use at baseline

Count of Participants

Participants

Title	Denominators	Categories
UFH and/or LMWH: Total	ParticipantsBG000274 ParticipantsBG001276 ParticipantsBG002

Time from study hospital presentation to treatment catheter insertion, hours

Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 5 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.

Mean

Standard Deviation

hours

Title	Denominators	Categories
	ParticipantsBG000271 ParticipantsBG001271 ParticipantsBG002

mPAP, mmHg

Data unavailable for 6 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 1 subject in the non-randomized cohort.

Mean

Standard Deviation

mmHg

Title	Denominators	Categories
	ParticipantsBG000274 ParticipantsBG001270 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Primary Endpoint: Composite Clinical Endpoint Constructed as a 5-Component Win Ratio

The primary endpoint is a composite constructed as a hierarchical win ratio of the following 5 components:

All-cause mortality, or
Intracranial hemorrhage (ICH), or
Major bleeding per ISTH definition, or
Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or
ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure.

A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.

Enrolled subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm and Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm were assessed for this Outcome Measure.

Posted

Number

Number of Wins for the group

Hospital discharge or at 7 days after the index procedure, whichever is sooner

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).

Units	Counts
Participants	OG000274 OG001276

Title

Denominators

Categories

Title	Measurements
	OG00052693 OG00110509

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Win Ratio	5.01			2-Sided	95	3.68	6.97					Superiority

Secondary

Composite Clinical Endpoint Constructed as a 4-Component Win Ratio

This secondary endpoint is a composite constructed as a hierarchical win ratio of the following 4 components:

All-cause mortality, or
Intracranial hemorrhage (ICH), or
Major bleeding per ISTH definition, or
Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy

A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.

Enrolled subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm and Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm were assessed for this Outcome Measure.

Posted

Number

Number of Wins for the group

Hospital discharge or at 7 days after the index procedure, whichever is sooner

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).

Secondary

All-cause Mortality

All enrolled subjects

Posted

Count of Participants

Participants

Hospital discharge or at 7 days after the index procedure, whichever is sooner

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants	OG000

Secondary

Intracranial Hemorrhage (ICH)

All enrolled subjects with available outcome

Posted

Count of Participants

Participants

Hospital discharge or at 7 days after the index procedure, whichever is sooner

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants	OG000

Secondary

Major Bleeding Per ISTH Definition

All enrolled subjects

Posted

Count of Participants

Participants

Hospital discharge or at 7 days after the index procedure, whichever is sooner

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants	OG000

Secondary

Clinical Deterioration Defined by Hemodynamic or Respiratory Worsening, and/or Escalation to a Bailout Therapy

Clinical deterioration is defined as documented objective hemodynamic or respiratory worsening that is new (i.e. not present at the time of enrollment).

Bailout therapy is an unplanned escalation of therapeutic measures, taken when the patient's condition has not improved or is not improving according to expectations.

All enrolled subjects

Posted

Count of Participants

Participants

Hospital discharge or at 7 days after the index procedure, whichever is sooner

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Secondary

ICU Admission During the Index Hospitalization and Following the Index Procedure

All enrolled subjects

Posted

Count of Participants

Participants

Hospital discharge or at 7 days after the index procedure, whichever is sooner

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants

Secondary

ICU Length of Stay During the Index Hospitalization and Following the Index Procedure Among Subjects With ICU Admission.

All enrolled subjects with available outcome

Posted

Count of Participants

Participants

Hospital discharge or at 7 days after the index procedure, whichever is sooner

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants

Secondary

All Cause Mortality

All enrolled subjects with available outcome

Posted

Count of Participants

Participants

30 days from index procedure

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants	OG000

Secondary

All-cause and PE-related Readmissions

All enrolled subjects with available outcome

Posted

Count of Participants

Participants

30 days from index procedure

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants	OG000

Secondary

Device-related Serious Adverse Events

Device-related SAEs included those adjudicated by the CEC to be related to the interventional device.

All enrolled subjects with available outcome

Posted

Count of Participants

Participants

Through the 30 day visit

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants

Secondary

Drug-related Serious Adverse Events

Drug-related SAEs included those adjudicated by the CEC to be related to anticoagulation and/or thrombolytics medication.

All enrolled subjects with available outcome

Posted

Count of Participants

Participants

Through the 30 day visit

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants

Secondary

Clinically Relevant Non-Major (CRNM) and Minor Bleeding Events

All enrolled subjects with available outcome

Posted

Count of Participants

Participants

Hospital discharge or at 7 days after the index procedure, whichever is sooner

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants

Secondary

Change in Right-ventricular/Left-ventricular (RV/LV) Ratio, as Measured by Echocardiography or CT

Assessments of change were made using the same imaging modality at baseline and at the 24-hour visit.

All enrolled subjects with available outcome

Posted

Mean

Standard Deviation

ratio

Baseline to 24 hour visit

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants

Secondary

Modified Medical Research Council (mMRC) Dyspnea Score at 24 Hour Visit

The mMRC score is reported on a 0-4 scale with lower scores representing less dyspnea.

All enrolled subjects with available outcome

Posted

Count of Participants

Participants

At 24 hour visit

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants

Secondary

Modified Medical Research Council (mMRC) Dyspnea Score at 30 Day Visit

The mMRC score is reported on a 0-4 scale with lower scores representing less dyspnea.

All enrolled subjects with available outcome

Posted

Count of Participants

Participants

At 30 day visit

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants

Secondary

Length of Total Hospital Stay

All enrolled subjects

Posted

Mean

Standard Deviation

hospital overnights

Through 30 days post-procedure

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants	OG000

Secondary

Length of Post-index-procedure Hospital Stay

All enrolled subjects

Posted

Mean

Standard Deviation

days

Through 30 days post-procedure

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Units	Counts
Participants	OG000

Secondary

Pulmonary Embolism Quality of Life (PEmb-QOL) Score at 30 Day Visit

The Pulmonary Embolism Quality of Life (PEmb-QOL) questionnaire is used to assess the quality of life in patients with pulmonary embolism (PE). It is a disease-specific tool designed to evaluate the impact of PE on various aspects of a patient's life, including daily activities, work, social life, and emotional well-being, and is reported on a 0-100 scale with lower scores representing better quality of life.

All enrolled subjects with available outcome

Posted

Mean

Standard Deviation

score on a scale

At 30 day visit

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Secondary

EQ-5D-5L Quality of Life Score at 30 Day Visit

Each of the five dimensions comprising the EQ-5D-5L descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) are graded from 1 (no problems) to 5 (extreme problems). A descriptive health state is defined by combining each level for 5 dimensions into a 5-digit code (e.g., 12345) which is then mapped to the health state index score based on a country-specific value set. Health state index scores range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health).

All enrolled subjects with available outcome

Posted

Mean

Standard Deviation

score on a scale

At 30 day visit

ID	Title	Description
OG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
OG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
OG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Deep vein thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected274 at risk EG0011 affected276 at risk EG0021 affected142 at risk
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected274 at risk EG0013 affected276 at risk EG0021 affected142 at risk
Syncope	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Abdominal wall haematoma	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Cerebral haemorrhage	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Cerebrovascular accident	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0022 affected142 at risk
Haematoma	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Heparin-induced thrombocytopenia	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Postmenopausal haemorrhage	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Pulmonary embolism	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0014 affected276 at risk EG0021 affected142 at risk
Chest wall haematoma	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Embolic stroke	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Gangrene	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Haematoma muscle	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Haemorrhage	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Hypertensive emergency	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Presyncope	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Vascular access site haematoma	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0007 affected274 at risk EG0017 affected276 at risk EG0021 affected142 at risk
Vascular access site haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0003 affected274 at risk EG0011 affected276 at risk EG0021 affected142 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Catheter site haematoma	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0021 affected142 at risk
Orbital haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Postoperative wound infection	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0025 affected142 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0011 affected276 at risk EG0023 affected142 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Dyspnoea	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Atrial flutter	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Bradycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0022 affected142 at risk
Pericardial effusion	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0022 affected142 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected274 at risk EG0012 affected276 at risk EG0022 affected142 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0013 affected276 at risk EG0021 affected142 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0022 affected142 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Melaena	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Mesenteric neoplasm	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0021 affected142 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Bacteraemia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Diverticulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Septic shock	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0011 affected276 at risk EG0022 affected142 at risk
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0021 affected142 at risk
Sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Haematuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected274 at risk EG0012 affected276 at risk EG0021 affected142 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0012 affected276 at risk EG0021 affected142 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Renal transplant failure	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Haemoglobin decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 affected274 at risk EG0012 affected276 at risk EG0020 affected142 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Alcohol withdrawal syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0012 affected276 at risk EG0020 affected142 at risk
Death	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Generalised oedema	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Vessel puncture site haematoma	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0012 affected276 at risk EG0020 affected142 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Paraesthesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0012 affected276 at risk EG0020 affected142 at risk
Catheter directed thrombolysis	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Thrombectomy	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Arterial puncture	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Lung assist device therapy	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Osteorrhagia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Mental status changes	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vascular access site haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0006 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Vascular access site haematoma	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0003 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Non-small cell lung cancer	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0012 affected276 at risk EG0020 affected142 at risk
Bradycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Arrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0021 affected142 at risk
Pericardial effusion	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0012 affected276 at risk EG0020 affected142 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Ascites	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Pharyngo-oesophageal diverticulum	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Endocarditis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Haematoma	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Cerebrovascular accident	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Epistaxis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Swelling face	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Necrosis	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Right ventricular systolic pressure decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Haemoglobin decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Oxygen saturation decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Respiratory rate increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Transaminases increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Mental status changes	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected274 at risk EG0010 affected276 at risk EG0020 affected142 at risk
Delirium	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0021 affected142 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0012 affected276 at risk EG0020 affected142 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0010 affected276 at risk EG0021 affected142 at risk
Metastatic uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk
Abortion induced	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 affected274 at risk EG0011 affected276 at risk EG0020 affected142 at risk

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
BG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
BG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Randomized Controlled Trial Cohort - FlowTriever Arm	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.	3	274	43	274	23	274
EG001	Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm	Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).	2	276	47	276	18	276
EG002	Non-Randomized Absolute Contraindication to Thrombolytics Cohort	Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.	6	142	35	142	13	142