Trial Outcomes & Findings for A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department (NCT NCT02584660)

Last Updated: 2018-06-01

Results Overview

Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

114 participants

Primary outcome timeframe

Up to Day 30

Results posted on

2018-06-01

Participant Flow

Of the 300 participants screened, 114 participants were randomized (51 to rivaroxaban group and 63 participants in the standard-of-care group) and 112 participants were treated and received at least 1 dose of study agent.

Participant milestones

Participant milestones
Measure	Rivaroxaban Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
Overall Study STARTED	51	63
Overall Study Treated	49	63
Overall Study COMPLETED	44	55
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Rivaroxaban Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
Overall Study Adverse Event	4	0
Overall Study Lost to Follow-up	3	4
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	0	2
Overall Study Other	0	1

Baseline Characteristics

A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rivaroxaban n=51 Participants Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care n=63 Participants Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.	Total n=114 Participants Total of all reporting groups
Age, Continuous	49.1 years STANDARD_DEVIATION 13.27 • n=5 Participants	47.6 years STANDARD_DEVIATION 17.22 • n=7 Participants	48.3 years STANDARD_DEVIATION 15.53 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	31 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	60 Participants n=7 Participants	107 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	48 Participants n=7 Participants	77 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	29 Participants n=5 Participants	48 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	47 Participants n=5 Participants	60 Participants n=7 Participants	107 Participants n=5 Participants
Region of Enrollment UNITED STATES	51 Participants n=5 Participants	63 Participants n=7 Participants	114 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 30

Population: The intention to treat analysis set (ITT) included all participants who were randomized into the study.

Outcome measures

Outcome measures
Measure	Rivaroxaban n=51 Participants Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care n=63 Participants Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
Mean Duration of Hospitalization	0.191 Days Standard Deviation 0.6862	1.393 Days Standard Deviation 1.9642

SECONDARY outcome

Timeframe: Up to 7, 14, 30, and 90 Days

Population: The ITT included all participants who were randomized into the study.

Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed.

Outcome measures

Outcome measures
Measure	Rivaroxaban n=51 Participants Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care n=63 Participants Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death Up to 7 Days	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death Up to 14 Days	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death Up to 30 Days	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death Up to 90 Days	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 7, 14, 30 and 90 Days

Population: The ITT included all participants who were randomized into the study.

Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.

Outcome measures

Outcome measures
Measure	Rivaroxaban n=51 Participants Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care n=63 Participants Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding Up to 7 Days	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding Up to 14 Days	2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding Up to 30 Days	3.9 Percentage of Participants	1.6 Percentage of Participants
Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding Up to 90 Days	3.9 Percentage of Participants	6.3 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 30 and 90 Days

Population: The ITT included all participants who were randomized into the study.

Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.

Outcome measures

Outcome measures
Measure	Rivaroxaban n=51 Participants Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care n=63 Participants Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason Within 30 Days	0.679 Days Standard Deviation 2.0894	1.513 Days Standard Deviation 1.9952
Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason Within 90 Days	0.764 Days Standard Deviation 2.1829	1.812 Days Standard Deviation 2.714

SECONDARY outcome

Timeframe: Day 90

Population: The safety population included all randomized participants who took at least 1 dose of study drug.

ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 \[how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.

Outcome measures

Outcome measures
Measure	Rivaroxaban n=49 Participants Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care n=63 Participants Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 13: Moderately	4.4 Percentage of participants	14.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 13: Extremely	0 Percentage of participants	5.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 14: Not at all	4.4 Percentage of participants	5.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 14: A little	8.9 Percentage of participants	7.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 15: Quite a bit	35.6 Percentage of participants	42.6 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 16: A little	2.2 Percentage of participants	9.1 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 16: Quite a bit	33.3 Percentage of participants	45.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 3: Quite a bit	4.4 Percentage of participants	5.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 9: Quite a bit	0 Percentage of participants	1.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 10: Extremely	2.2 Percentage of participants	10.9 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 12: Extremely	0 Percentage of participants	3.7 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 13: Not at all	64.4 Percentage of participants	54.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 13: A little	28.9 Percentage of participants	18.2 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 17: Moderately	17.8 Percentage of participants	18.2 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 17: Quite a bit	28.9 Percentage of participants	43.6 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 17: Extremely	37.8 Percentage of participants	23.6 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 8: Moderately	0 Percentage of participants	7.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 8: Quite a bit	2.2 Percentage of participants	1.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 8: Extremely	0 Percentage of participants	0 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 9: Not at all	84.4 Percentage of participants	74.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 9: A little	15.6 Percentage of participants	21.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 9: Moderately	0 Percentage of participants	1.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 1: Not at all	51.1 Percentage of participants	61.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 1: A little	40 Percentage of participants	21.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 1: Moderately	6.7 Percentage of participants	10.9 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 1: Quite a bit	2.2 Percentage of participants	1.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 1: Extremely	0 Percentage of participants	3.6 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 2: Not at all	77.8 Percentage of participants	70.9 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 2: A little	13.3 Percentage of participants	20 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 2: Moderately	6.7 Percentage of participants	7.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 2: Quite a bit	2.2 Percentage of participants	0 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 2: Extremely	0 Percentage of participants	1.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 3: Not at all	71.1 Percentage of participants	65.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 3: A little	22.2 Percentage of participants	21.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 3: Moderately	2.2 Percentage of participants	5.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 3: Extremely	0 Percentage of participants	1.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 4: Not at all	60 Percentage of participants	52.7 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 4: A little	33.3 Percentage of participants	20 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 4: Moderately	4.4 Percentage of participants	9.1 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 4: Quite a bit	2.2 Percentage of participants	10.9 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 4: Extremely	0 Percentage of participants	7.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 5: Not at all	80 Percentage of participants	60 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 5: A little	17.8 Percentage of participants	16.4 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 5: Moderately	0 Percentage of participants	16.4 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 5: Quite a bit	2.2 Percentage of participants	7.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 5: Extremely	0 Percentage of participants	0 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 6: Not at all	75.6 Percentage of participants	56.4 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 6: A little	20 Percentage of participants	25.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 14: Moderately	20 Percentage of participants	21.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 6: Moderately	2.2 Percentage of participants	5.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 15: Not at all	4.4 Percentage of participants	5.6 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 14: Quite a bit	26.7 Percentage of participants	38.2 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 6: Quite a bit	2.2 Percentage of participants	12.7 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 13: Quite a bit	2.2 Percentage of participants	7.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 14: Extremely	40 Percentage of participants	27.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 6: Extremely	0 Percentage of participants	0 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 7: Not at all	73.3 Percentage of participants	45.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 7: A little	22.2 Percentage of participants	30.9 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 7: Moderately	4.4 Percentage of participants	20 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 7: Quite a bit	0 Percentage of participants	1.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 15: A little	8.9 Percentage of participants	5.6 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 7: Extremely	0 Percentage of participants	1.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 15: Moderately	20 Percentage of participants	24.1 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 8: Not at all	82.2 Percentage of participants	78.2 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 8: A little	15.6 Percentage of participants	12.7 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 15: Extremely	31.1 Percentage of participants	22.2 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 16: Not at all	8.9 Percentage of participants	5.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 16: Moderately	15.6 Percentage of participants	9.1 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 16: Extremely	40 Percentage of participants	30.9 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 17: Not at all	2.2 Percentage of participants	7.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 17: A little	13.3 Percentage of participants	7.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 9: Extremely	0 Percentage of participants	0 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 10: Not at all	48.9 Percentage of participants	43.6 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 10: A little	28.9 Percentage of participants	16.4 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 10: Moderately	8.9 Percentage of participants	18.2 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 10: Quite a bit	11.1 Percentage of participants	10.9 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 11: Not at all	77.8 Percentage of participants	60 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 11: A little	17.8 Percentage of participants	16.4 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 11: Moderately	4.4 Percentage of participants	7.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 11: Quite a bit	0 Percentage of participants	9.1 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 11: Extremely	0 Percentage of participants	7.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 12: Not at all	84.4 Percentage of participants	64.8 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 12: A little	15.6 Percentage of participants	18.5 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 12: Moderately	0 Percentage of participants	9.3 Percentage of participants
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS) Item 12: Quite a bit	0 Percentage of participants	3.7 Percentage of participants

SECONDARY outcome

Timeframe: Day 7

Population: The safety population included all randomized participants who took at least 1 dose of study drug.

The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction.

Outcome measures

Outcome measures
Measure	Rivaroxaban n=49 Participants Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care n=63 Participants Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Satisfaction level: Very Satisfied	60.4 Percentage of participants	62.7 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Satisfaction level: Quite Satisfied	33.3 Percentage of participants	23.7 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Satisfaction level: Neither	4.2 Percentage of participants	6.8 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Satisfaction level: Quite Dissatisfied	2.1 Percentage of participants	5.1 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Satisfaction level: Very Dissatisfied	0 Percentage of participants	1.7 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Location of care: Very Satisfied	62.5 Percentage of participants	59.3 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Location of care: Quite Satisfied	33.3 Percentage of participants	30.5 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Location of care: Neither	4.2 Percentage of participants	6.8 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Location of care: Quite Dissatisfied	0 Percentage of participants	1.7 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Location of care: Very Dissatisfied	0 Percentage of participants	1.7 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Preference of care: In the Hospital	18.8 Percentage of participants	47.5 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Preference of care: In the Community	50 Percentage of participants	40.7 Percentage of participants
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire Preference of care: No Preference	31.3 Percentage of participants	11.9 Percentage of participants

Adverse Events

Rivaroxaban

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Standard-of-care

Serious events: 7 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rivaroxaban n=49 participants at risk Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care n=63 participants at risk Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
Cardiac disorders Atrial Fibrillation	2.0% 1/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	0.00% 0/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
General disorders Chest Pain	2.0% 1/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	0.00% 0/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
General disorders Pain	2.0% 1/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	0.00% 0/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
General disorders Systemic Inflammatory Response Syndrome	0.00% 0/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	1.6% 1/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Infections and infestations Device Related Infection	2.0% 1/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	0.00% 0/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Infections and infestations Embolic Pneumonia	0.00% 0/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	1.6% 1/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	1.6% 1/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Infections and infestations Sepsis	2.0% 1/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	0.00% 0/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	2.0% 1/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	0.00% 0/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	1.6% 1/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	4.8% 3/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	2.0% 1/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	0.00% 0/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Vascular disorders May-Thurner Syndrome	0.00% 0/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	1.6% 1/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Vascular disorders Thrombosis	0.00% 0/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	1.6% 1/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Rivaroxaban n=49 participants at risk Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally.	Standard-of-care n=63 participants at risk Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants.
General disorders Chest Pain	10.2% 5/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	4.8% 3/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
General disorders Non-Cardiac Chest Pain	0.00% 0/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	3.2% 2/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Infections and infestations Sinusitis	4.1% 2/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	0.00% 0/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Injury, poisoning and procedural complications Head Injury	0.00% 0/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	3.2% 2/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back Pain	4.1% 2/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	1.6% 1/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle Spasms	4.1% 2/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	0.00% 0/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in Extremity	6.1% 3/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	0.00% 0/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Nervous system disorders Headache	4.1% 2/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	4.8% 3/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Reproductive system and breast disorders Menorrhagia	6.1% 3/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	1.6% 1/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	7.9% 5/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.1% 2/49 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.	1.6% 1/63 • Approximately 2.5 years The safety population included all randomized participants who took at least 1 dose of study drug.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
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Restriction type: OTHER