RE-COVERY DVT/PE: Global Study on Treatment Secondary Pre... | NCT02596230

Label	Type	Description	Intervention Names
Patients with acute VTE		Patients will be enrolled for cross sectional characterization of baseline characteristics
Dabigatran		Patients treated with dabigatran for acute VTE will be followed for one year
vitamin K antagonist		Patients treated with VKA for acute VTE will be followed for one year

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective 1: Age	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.	Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Objective 1: Sex	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.	Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Objective 1: Index Event	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.

Secondary Outcomes

Measure	Description	Time Frame
Objective 2: Incidence Rate of Recurrent DVT and/or PE	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.

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Innovation and Research Center		Long Beach	California	90813	United States
Health and Life Research Institute, LLC

PubMed Identifier	Type	Citation	Retractions
34453675	Derived	Goldhaber SZ, Ageno W, Casella IB, Chee KH, Schellong S, Singer DE, Voccia I, Tang W, Schulman S. Safety and effectiveness of dabigatran in routine clinical practice: the RE-COVERY DVT/PE study. J Thromb Thrombolysis. 2022 Feb;53(2):399-409. doi: 10.1007/s11239-021-02463-x. Epub 2021 Aug 28.
32851572	Derived

ID	Title	Description
FG000	Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with either Edoxaban, Rivaroxaban, Apixaban or other anticoagulation treatments. Participants analyzed for objective 1 only.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Apr 5, 2017	Mar 25, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Objective 1: Age

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.

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

Posted

Mean

Standard Deviation

years

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

ID	Title	Description
OG000	All Participants With a DVT and/or PE	All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).

Units	Counts
Participants	OG0006095

Title

Denominators

Categories

Title	Measurements
	OG00061.5± 17.0

Primary

Objective 1: Sex

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	All Participants With a DVT and/or PE	All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).

Units	Counts

Primary

Objective 1: Index Event

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	All Participants With a DVT and/or PE	All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).

Primary

Objective 1: Anticoagulant Treatment

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	All Participants With a DVT and/or PE	All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).

Primary

Objective 2: Incidence Rate of ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding and CRNMB (Clinically Relevant Non Major Bleeding) Per 100 Patient-years (Pt-yrs)

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.

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.

Posted

Number

95% Confidence Interval

events per 100 patient-years

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

ID	Title	Description
OG000	Dabigatran Etexilate	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
OG001	Vitamin K Antagonist

Primary

Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality

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.

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.

Posted

Number

95% Confidence Interval

events per 100 patient-years

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

ID	Title	Description
OG000	Dabigatran Etexilate	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
OG001	Vitamin K Antagonist

Secondary

Objective 2: Incidence Rate of Recurrent DVT and/or PE

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.

Posted

Number

95% Confidence Interval

events per 100 patient-years

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

ID	Title	Description
OG000	Dabigatran Etexilate	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
OG001	Vitamin K Antagonist

Secondary

Objective 2: Incidence Rate of VTE-related Mortality

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.

Posted

Number

95% Confidence Interval

events per 100 patient-years

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

ID	Title	Description
OG000	Dabigatran Etexilate	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
OG001	Vitamin K Antagonist	Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.

Secondary

Objective 2: Incidence Rate of All-cause Mortality

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.

Posted

Number

95% Confidence Interval

events per 100 patient-years

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

ID	Title	Description
OG000	Dabigatran Etexilate	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
OG001	Vitamin K Antagonist	Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG0030 affected1,375 at risk EG004
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0005 affected3,714 at risk EG0010 affected1,006 at risk EG0025 affected910 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0011 affected1,006 at risk EG0024 affected910 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Pulseless electrical activity	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Right-to-left cardiac shunt	Congenital, familial and genetic disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0003 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Death	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0007 affected3,714 at risk EG0013 affected1,006 at risk EG0026 affected910 at risk EG003
Drug intolerance	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Oedema peripheral	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Peripheral swelling	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Sudden death	General disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0002 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Sepsis	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0003 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Septic shock	Infections and infestations	MedDRA 21.1	Non-systematic Assessment	EG0003 affected3,714 at risk EG0011 affected1,006 at risk EG0021 affected910 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Blood urine present	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
International normalised ratio increased	Investigations	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0002 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0002 affected3,714 at risk EG0011 affected1,006 at risk EG0022 affected910 at risk EG003
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0002 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Testicular cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Cerebellar haematoma	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Coma	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0012 affected1,006 at risk EG0021 affected910 at risk EG003
Nephroptosis	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Non-systematic Assessment	EG0002 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0005 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0023 affected910 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Abortion induced	Surgical and medical procedures	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0011 affected1,006 at risk EG0020 affected910 at risk EG003
Arterial rupture	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Haematoma	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Internal haemorrhage	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0000 affected3,714 at risk EG0010 affected1,006 at risk EG0021 affected910 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Non-systematic Assessment	EG0001 affected3,714 at risk EG0010 affected1,006 at risk EG0020 affected910 at risk EG003

ID	Title	Description
BG000	Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with either Edoxaban, Rivaroxaban, Apixaban or other anticoagulation treatments. Participants analyzed for objective 1 only.
BG001	Dabigatran Etexilate (1)	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. Participants analyzed for objective 1 or for objective 1 and 2.
BG002	Dabigatran Etexilate (2)	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. New participants analyzed for objective 2 only.
BG003	Vitamin K Antagonist (1)	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. Participants analyzed for objective 1 or for objective 1 and 2.
BG004	Vitamin K Antagonist (2)	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. New participants analyzed for objective 2 only.
BG005	Total	Total of all reporting groups

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with either Edoxaban, Rivaroxaban, Apixaban or other anticoagulation treatments. Participants analyzed for objective 1 only.	54	3,714	60	3,714	3,714
EG001	Dabigatran Etexilate (1)	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. Participants analyzed for objective 1 or for objective 1 and 2.	13	1,006	22	1,006	1,006
EG002	Dabigatran Etexilate (2)	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. New participants analyzed for objective 2 only.	42	910	47	910	910
EG003	Vitamin K Antagonist (1)	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. Participants analyzed for objective 1 or for objective 1 and 2.	25	1,375	34	1,375	1,375
EG004	Vitamin K Antagonist (2)	Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. New participants analyzed for objective 2 only.	30	792	41	792	792