Peacock 2018.

Study characteristics
Methods	Design: international, open‐label, randomised, parallel group, multicentre Multicentre study: 35 sites in the USA Sample size: 114 Follow‐up: 90 days after randomisation
Participants	Inclusion criteria: adult patients (age ≥ 18 years) with objectively confirmed PE (with or without symptomatic DVT) deemed to be at low risk for recurrent VTE, major bleeding, or all‐cause mortality based on Hestia criteria, and a life expectancy of at least 6 months. The authors adapted the Hestia criteria by removing the 24‐hour time markers. Exclusion criteria: women of childbearing age with no use of a highly effective birth control method, patients with any Hestia criteria present, any concomitant contraindicated medications, and individuals with contraindications to anticoagulant therapy, allergies to rivaroxaban, or with barriers to treatment adherence or follow‐up
Interventions	Intervention (N = 51): outpatient treatment with rivaroxaban 15 mg orally twice daily for the first 21 days followed by 20 mg orally once daily for approximately 69 days, for a total treatment duration of 90 days. Comparison (N = 63): local standard of care, participants received local standard of care according to local protocol and defined by the medical team caring for the participant, which typically involves bridging therapy and hospitalisation, but also any of the NOACs.
Outcomes	Mean duration of hospitalisation expressed in hours for venous thromboembolic or bleeding events, in the 30 days after randomisation Major bleeding based on the ISTH within 90 days Percentage of participants with new/recurrence of VTE, or VTE‐related death, within 7, 14, 30, or 90 days from randomisation Percentage of participants with number of unplanned visits to the hospital or physician office for VTE symptoms or bleeding (up to 7, 14, 30 and 90 days) Mean combined duration of initial and subsequent ED hospitalisation for any reason (up to 30 and 90 days) Percentage of participants satisfied using site‐of‐care satisfaction questionnaire (day 7) and by ACTS (day 90) Clinically relevant non‐major bleeding, based on ISTH definitions Total, all‐cause mortality Total, serious adverse events Costs
Funding	Quote: "Funding for this research was provided by Janssen Pharmaceuticals, Raritan, NJ"
Declarations of interest	Quote: "Consulting for commercial interests, including advisory board work—WFP, CC, DD, and AS have received funding personally from Janssen for consulting. WFP, and CC have received funding personally from Bayer, AG. JK has received grant funding from Janssen for a separate study. Payment for writing independent of grant funding—No author received payment from [sic] for writing any part of this manuscript. Employment—PW and JX are employed by Janssen, which manufactures rivaroxaban. Institutional Grant Receipt—WFP, CC, DD, SF, CKa, CKe, JM, and AS’s institution has received funding from Janssen for this investigator‐initiated research. Miscellaneous—DD has been a member of the SAEM board of directors."
Notes	The authors used the Hestia criteria to classify patients, therefore we considered that most patients were symptomatic.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	They used an interactive web system. Quote: "After obtaining written informed consent, patients were randomly assigned in a 1:1 ratio to ED discharge on open‐label rivaroxaban or standard care (as determined by the attending physician) by an interactive Web system within 12 hours of diagnosis."
Allocation concealment (selection bias)	Low risk	They used an interactive web system. Quote: "After obtaining written informed consent, patients were randomly assigned in a 1:1 ratio to ED discharge on open‐label rivaroxaban or standard care (as determined by the attending physician) by an interactive Web system within 12 hours of diagnosis."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The analysers were masked to treatment group assignment. Quote: "Principal investigators and outcome adjudicators were masked to group assignment"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Less than 20% of dropouts and withdrawals (7 participants in the outpatient group and 8 participants in the inpatient group); however, the authors did not perform intention‐to‐treat analysis. All outpatients completed the study, and authors could confirm that all of them were alive; however, they could not confirm this for two patients in the inpatient group.
Selective reporting (reporting bias)	Low risk	There is no evidence of selective reporting.
Other bias	Low risk	We did not find aspects of methodology that might be been influenced by vested interests and which may lead directly to a risk of bias. However, comparison of two sites of care (inpatient versus outpatient) was imbalanced by different pharmacotherapy between the arms: the outpatient group received 15 mg oral rivaroxaban twice daily for the first 21 days, followed by 20 mg oral rivaroxaban once daily for approximately 69 days for a total treatment duration of 90 days. The inpatient comparison group received local standard‐of‐care, according to local protocol and defined by the medical team caring for the participant, which typically involved intravenous UFH or subcutaneous LMWH and hospitalisation, but also included any of the NOACs (75% of all patients were initially treated with unfractionated or low‐molecular‐weight heparin but ultimately received NOACs, most commonly rivaroxaban (51%) or apixaban (25%)).

ACTS: anti‐clot treatment scale; CT: computed tomography; DVT: deep vein thrombosis; ED: emergency department; HIT: heparin‐induced thrombocytopenia; ISTH: International Society on Thrombosis and Haemostasis;LMWH: low molecular weight heparin; NOACs: non‐vitamin K antagonist oral anticoagulants; PE: pulmonary embolism;PESI: Pulmonary Embolism Severity Index; SBP: systolic blood pressure; UFH: unfractionated heparin; VTE: venous thromboembolism.