Total VTE was defined as the composite of clinical events committee (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.

The modified Intent-to-treat (mITT) analysis set included all intent-to-treat (ITT) participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic proximal DVT, PE or death as adjudicated by the CEC.

Any bleeding was defined as the composite of major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria modified for the surgical setting, clinically relevant nonmajor bleeding events, or minimal bleeding events as assessed by the CEC.

The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.

Total VTE was defined as the composite of (CEC-adjudicated) proximal and/or DVT (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal PE, or any death.

The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52. Also included the participants whose venography result was not evaluable distal but no proximal clot.

Composite of Major bleeding event (BE): 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, deep wound infection and/or either 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 is still considered clinically relevant for example: Epistaxis, Gastrointestinal bleed,Hematuria,Bruising/ecchymosis,Hemoptysis,Hematoma.

The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.

Number of participants with major BE (adjudicated by CEC) were reported. Major Bleeding events were defined as: 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; requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.

The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.

Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.

The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of 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. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.

The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.

Major Bleeding events were defined as: 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; requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; either 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 is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.

The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.

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.

The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52.

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.

The mITT analysis set at Day 14 included all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE 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.

The mITT analysis set at Day 14 includes all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE or any death). Also includes the subjects whose venography result is not evaluable distal but no proximal clot.

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

The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52 and also included the participants whose venography result was not evaluable distal but no proximal clot.

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

The mITT analysis set at Day 14 included all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE 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.

The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52.

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

The mITT analysis set at Day 14 included all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE or any death).

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

The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52.

Number of participants with deaths (CEC-adjudicated) were reported.

The mITT analysis set at Day 14 included all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE or any death).

Number of participants with deaths (CEC-adjudicated) were reported.

The mITT analysis set included all the participants in mITT at Day 14 plus the participants who had symptomatic/asymptomatic VTE events (DVT, non-fatal PE or any death) after day 17 through day 52.

Apparent clearance of a drug was defined as a measure of the rate at which a drug got metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.

The pharmacokinetic (PK) analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for overall participants and not group wise.

V/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.

The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for overall participants and not group wise.

Impact of demographic character (sex) on CL/F was assessed.

The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on sex (male and female) to report the effect of sex on CL/F.

Impact of age on CL/F was assessed.

The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on age to report the effect of age on CL/F.

Impact of weight on CL/F was assessed.

The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on weight to report the effect of weight on CL/F.

Impact of renal function on CL/F was assessed. The outcome measure was reported based on CRCL.

The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on CRCL to report the effect of renal function on CL/F.

Impact of sex on V/F was assessed.

The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on sex (male and female) to report the effect of sex on V/F.

Impact of age on V/F was assessed.

The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on age to report the effect of age on V/F.

Impact of weight on V/F was assessed.

The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on weight to report the effect of weight on V/F.

Impact of renal function on V/F was assessed. The outcome measure is reported based on CRCL.

The PK analysis set consisted of participants who received at least 1 dose of milvexian and had at least one valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Arms are created based on CRCL to report the effect of renal function on V/F.

The dose-response trend test based on the MCP-Mod framework consisted of contrast tests defined by prespecified candidate models (4 Emax dose-response models with varying degrees of ED50). Each model was evaluated for significance of trend, based on its optimal contrast, resulting in four t-test statistics, one for each candidate model. The t-test statistics were adjusted for the fact that 4 candidate models were included in the trend testing. The dose response of the drug was then established if the maximum of the t-test statistics exceeded the 95th percentile critical value. Here 'number' signifies the estimated response rate.

The mITT analysis set at Day 14 included all ITT participants who received at least 1 dose of study drug with an evaluable venography assessment or a confirmed symptomatic VTE event (DVT, non-fatal PE or any death).

The dose-response trend test based on the MCP-Mod framework consisted of contrast tests defined by prespecified candidate models (4 Emax dose-response models with varying degrees of ED50). Each model was evaluated for significance of trend, based on its optimal contrast, resulting in four t-test statistics, one for each candidate model. The t-test statistics were adjusted for the fact that 4 candidate models were included in the trend testing. The dose response of the drug was then established if the maximum of the t-test statistics exceeded the 95th percentile critical value. Here 'number' signifies the estimated response rate.

The safety analysis set was a subset of the ITT analysis set, consisting of all ITT participants who received at least 1 dose (partial or complete) of study drug.