RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism

Age in years of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen. The arm presented in this endpoint was separated into three arms in the participant flow tables (Not assigned to Dabigatran etexilate or Vitamin K antagonist,Dabigatran etexilate (1) and Vitamin K antagonist (1)) in order to distinguish patients participating in both objectives from patients only in objective 2.

Time frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Population: All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population

Type of treatment received following acute Venous Thromboembolism (VTE) event of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen. The arm presented in this endpoint was separated into three arms in the participant flow tables (Not assigned to Dabigatran etexilate or Vitamin K antagonist,Dabigatran etexilate (1) and Vitamin K antagonist (1)) in order to distinguish patients participating in both objectives from patients only in objective 2.

Time frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Population: All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population.

Type of index event (e.g., DVT or PE or DVT and PE) diagnosed at the time of acute Venous Thromboembolism (VTE) event of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen. The arm presented in this endpoint was separated into three arms in the participant flow tables (Not assigned to Dabigatran etexilate or Vitamin K antagonist,Dabigatran etexilate (1) and Vitamin K antagonist (1)) in order to distinguish patients participating in both objectives from patients only in objective 2.

Time frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Population: All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population.

Sex of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen. The arm presented in this endpoint was separated into three arms in the participant flow tables (Not assigned to Dabigatran etexilate or Vitamin K antagonist,Dabigatran etexilate (1) and Vitamin K antagonist (1)) in order to distinguish patients participating in both objectives from patients only in objective 2.

Time frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Population: All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population.

Incidence rate of ISTH (International Society on Thrombosis and Haemostasis) major bleeding and CRNMB (clinically relevant non major bleeding) per 100 patient-years (1/(100\*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model. For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.

Time frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Population: Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap and who took the prescribed treatment at least once.

Incidence rate of Symptomatic Recurrent VTE (Venous Thromboembolism) including VTE related mortality per 100 patient-years (1/(100\*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model. For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.

Time frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Population: Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.

Incidence rate of all-cause mortality per 100 patient-years (1/(100\*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model. For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.

Time frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Population: Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.

Incidence rate of Recurrent Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE) per 100 patient-years (1/(100\*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model. For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.

Time frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Population: Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.

Incidence rate of VTE-related Mortality per 100 patient-years (1/(100\*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model. For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.

Time frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Population: Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.