Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery (NCT NCT03251482)

NCT ID: NCT03251482

Last Updated: 2019-11-25

Results Overview

Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 308 participants
• Primary outcome timeframe: Up to Day 10 to 14 (visit observation period)
• Results posted on: 2019-11-25

Participant Flow

The study was planned to be conducted in 2 parts: Part 1 (Dose- Escalation) and Part 2 (Dose-Response). After completion of Part 1, the sponsor made the decision to not move forward with Part 2 as there was sufficient data to make a determination of efficacy in Part 1. Part 2 was not conducted, hence endpoints for Part 2 are not reported.

Participant milestones

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Overall Study STARTED	39	41	43	122	63
Overall Study Treated	38	40	42	122	63
Overall Study COMPLETED	39	40	43	122	63
Overall Study NOT COMPLETED	0	1	0	0	0

Reasons for withdrawal

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Overall Study Withdrawal by Subject	0	1	0	0	0

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery

Baseline characteristics by cohort

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=38 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=40 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=42 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=122 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=63 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.	Total n=305 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 7.53 • n=5 Participants	65.8 years STANDARD_DEVIATION 8.14 • n=7 Participants	66.9 years STANDARD_DEVIATION 6.41 • n=5 Participants	67.2 years STANDARD_DEVIATION 8.84 • n=4 Participants	65.1 years STANDARD_DEVIATION 7.01 • n=21 Participants	66.4 years STANDARD_DEVIATION 7.92 • n=10 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	25 Participants n=7 Participants	35 Participants n=5 Participants	99 Participants n=4 Participants	42 Participants n=21 Participants	222 Participants n=10 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	15 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants	21 Participants n=21 Participants	83 Participants n=10 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	5 Participants n=21 Participants	16 Participants n=10 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants
Race/Ethnicity, Customized White	36 Participants n=5 Participants	39 Participants n=7 Participants	39 Participants n=5 Participants	110 Participants n=4 Participants	54 Participants n=21 Participants	278 Participants n=10 Participants
Race/Ethnicity, Customized Unspecified	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	8 Participants n=10 Participants
Region of Enrollment Argentina	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	27 Participants n=10 Participants
Region of Enrollment Belgium	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	16 Participants n=10 Participants
Region of Enrollment Bulgaria	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Region of Enrollment Canada	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Region of Enrollment Italy	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=10 Participants
Region of Enrollment Japan	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	12 Participants n=10 Participants
Region of Enrollment Latvia	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	12 Participants n=10 Participants
Region of Enrollment Lithuania	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	1 Participants n=21 Participants	12 Participants n=10 Participants
Region of Enrollment Malaysia	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants
Region of Enrollment Poland	17 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	18 Participants n=4 Participants	12 Participants n=21 Participants	60 Participants n=10 Participants
Region of Enrollment Russian Federation	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	3 Participants n=21 Participants	14 Participants n=10 Participants
Region of Enrollment Spain	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	2 Participants n=21 Participants	18 Participants n=10 Participants
Region of Enrollment Turkey	1 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	2 Participants n=21 Participants	23 Participants n=10 Participants
Region of Enrollment Ukraine	0 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants	7 Participants n=21 Participants	38 Participants n=10 Participants
Region of Enrollment United States	10 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	15 Participants n=4 Participants	12 Participants n=21 Participants	56 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).

Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=38 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=40 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=42 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=122 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=63 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)	2 Participants	0 Participants	5 Participants	1 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: Modified Intent-to-treat (mITT) analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death adjudicated by CEC.

Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=30 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=33 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=30 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=97 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=49 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)	10 Participants	9 Participants	9 Participants	31 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.

Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=38 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=40 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=42 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=122 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=63 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.

Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=38 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=40 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=42 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=122 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=63 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Major Bleeding Event (CEC-adjudicated)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.

Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=38 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=40 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=42 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=122 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=63 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10 and 14 (visit observation period)

Population: Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.

Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=38 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=40 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=42 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=122 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=63 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.

Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=38 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=40 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=42 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=122 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=63 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Minimal Bleeding Events (CEC-adjudicated)	2 Participants	0 Participants	4 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event or any death.

Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=30 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=33 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=30 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=97 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=49 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Major VTE (CEC-adjudicated)	2 Participants	2 Participants	1 Participants	7 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.

Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=30 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=33 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=30 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=97 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=49 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated) Asymptomatic	1 Participants	2 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated) Symptomatic	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.

Number of participants with nonfatal PE (adjudicated by CEC) were reported.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=30 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=33 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=30 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=97 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=49 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.

Number of participants with death (adjudicated by CEC) were reported.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=30 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=33 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=30 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=97 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=49 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Death (CEC-adjudicated)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.

Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=30 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=33 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=30 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=97 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=49 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Proximal and Distal DVT (CEC-adjudicated) Asymptomatic	1 Participants	0 Participants	1 Participants	4 Participants	0 Participants
Number of Participants With Proximal and Distal DVT (CEC-adjudicated) Symptomatic	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 10 to 14 (visit observation period)

Population: mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.

Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.

Outcome measures

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=30 Participants Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=33 Participants Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=30 Participants Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=97 Participants Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=49 Participants Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Number of Participants With Distal DVT (CEC-adjudicated) Asymptomatic	8 Participants	7 Participants	8 Participants	24 Participants	6 Participants
Number of Participants With Distal DVT (CEC-adjudicated) Symptomatic	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

Adverse Events

JNJ-64179375 0.3 mg/kg and Apixaban Placebo

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

JNJ-64179375 0.6 mg/kg and Apixaban Placebo

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

JNJ-64179375 1.2 mg/kg and Apixaban Placebo

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

JNJ-64179375 1.8 mg/kg and Apixaban Placebo

Serious events: 13 serious events

Other events: 37 other events

Deaths: 0 deaths

Apixaban 2.5 mg and JNJ-64179375 Placebo IV

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=38 participants at risk Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=40 participants at risk Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=42 participants at risk Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=122 participants at risk Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=63 participants at risk Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Musculoskeletal and connective tissue disorders Joint Contracture	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Cardiac disorders Angina Unstable	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Endocrine disorders Primary Hyperaldosteronism	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Gastrointestinal disorders Ascites	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Impaired Healing	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Oedema Peripheral	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Peripheral Swelling	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Pyrexia	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Infections and infestations Herpes Zoster	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Infections and infestations Infection	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Infections and infestations Postoperative Wound Infection	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Infections and infestations Urinary Tract Infection	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Overdose	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Postoperative Wound Complication	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Wound Haemorrhage	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Stage 0, with Cancer in Situ	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Nervous system disorders Transient Ischaemic Attack	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Renal and urinary disorders Nephrolithiasis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Bloody Discharge	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Deep Vein Thrombosis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	4.9% 6/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Post Thrombotic Syndrome	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).

Other adverse events

Measure	JNJ-64179375 0.3 mg/kg and Apixaban Placebo n=38 participants at risk Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.	JNJ-64179375 0.6 mg/kg and Apixaban Placebo n=40 participants at risk Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.2 mg/kg and Apixaban Placebo n=42 participants at risk Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	JNJ-64179375 1.8 mg/kg and Apixaban Placebo n=122 participants at risk Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.	Apixaban 2.5 mg and JNJ-64179375 Placebo IV n=63 participants at risk Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.
General disorders Catheter Site Haemorrhage	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Investigations Blood Thyroid Stimulating Hormone Increased	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Cardiac disorders Palpitations	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Ear and labyrinth disorders Vertigo	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Eye disorders Conjunctival Haemorrhage	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Gastrointestinal disorders Aphthous Ulcer	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Gastrointestinal disorders Constipation	5.3% 2/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	3.2% 2/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Gastrointestinal disorders Diarrhoea	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	5.0% 2/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 2/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Gastrointestinal disorders Food Poisoning	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Gastrointestinal disorders Nausea	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	7.5% 3/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	11.9% 5/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 3/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Gastrointestinal disorders Stomatitis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Gastrointestinal disorders Vomiting	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	4.8% 2/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 3/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Fat Necrosis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Feeling Hot	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Hyperthermia	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	4.8% 2/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Impaired Healing	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Injection Site Irritation	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Non-Cardiac Chest Pain	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Oedema Peripheral	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 2/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Peripheral Swelling	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
General disorders Pyrexia	15.8% 6/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	6.6% 8/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Infections and infestations Cystitis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Infections and infestations Gastroenteritis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Infections and infestations Urinary Tract Infection	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	7.1% 3/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Infections and infestations Wound Infection	5.3% 2/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Contusion	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	7.1% 3/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Patella Fracture	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Post Procedural Haematoma	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Post Procedural Swelling	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Procedural Haemorrhage	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	3.3% 4/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	3.2% 2/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Injury, poisoning and procedural complications Wound Haemorrhage	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	7.1% 3/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Investigations Blood Glucose Increased	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Investigations Blood Triglycerides Increased	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Investigations Body Temperature Increased	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Investigations Cardiovascular Evaluation	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Investigations Gamma-Glutamyltransferase Decreased	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Investigations Platelet Count Increased	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Metabolism and nutrition disorders Hyperglycaemia	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Metabolism and nutrition disorders Hyperkalaemia	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	11.9% 5/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 3/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 2/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Musculoskeletal and connective tissue disorders Haemarthrosis	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 2/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Nervous system disorders Dizziness Exertional	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Nervous system disorders Dizziness Postural	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Nervous system disorders Headache	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 3/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Nervous system disorders Neuralgia	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Nervous system disorders Syncope	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Psychiatric disorders Anxiety	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Psychiatric disorders Insomnia	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Psychiatric disorders Restlessness	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Renal and urinary disorders Renal Colic	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Skin and subcutaneous tissue disorders Pruritus Generalised	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Skin and subcutaneous tissue disorders Rash	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	5.0% 2/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Bloody Discharge	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Deep Vein Thrombosis	5.3% 2/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 2/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	4.8% 3/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Haematoma	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.82% 1/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Haemorrhage	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Hypertension	2.6% 1/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 1/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	3.3% 4/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	3.2% 2/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Hypotension	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	1.6% 1/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Peripheral Venous Disease	0.00% 0/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.5% 3/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
Vascular disorders Thrombophlebitis	5.3% 2/38 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/40 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	2.4% 1/42 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/122 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).	0.00% 0/63 • Up to 18 weeks Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).

Additional Information

Senior Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER