Thromboembolism
Conditions
Brief summary
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.
Interventions
DRUGWarfarin
PRN (to maintain a target INR of 2.0-3.0)
DRUGDabigatran etexilate
150mg bid
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE) * Male or female, being 18 years of age or older * Written informed consent for study participation
Exclusion criteria
* Persistent symptoms of VTE * PE requiring urgent intervention * Use of vena cava filter * Contraindications to anticoagulant therapy * Allergy to study medications * Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) \> 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival * Severe renal impairment * Patients considered unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180) | All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrent Symptomatic DVT | For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
| Number of Participants With Recurrent Symptomatic Non-fatal PE | For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
| Number of Participants Who Died Due to VTE | From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224) | VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events. |
| Number of Participants Who Died (Any Cause) | For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
| Number of Participants With Recurrent Symptomatic VTE and All Deaths | For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
| Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events | From first intake of study drug to last intake of study drug + 6 days washout | Major bleeding events (MBE) are defined as * Fatal bleeding * Symptomatic bleeding in a critical area or organ * Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells Clinically-relevant bleeding events (CRBE) are defined as * spontaneous skin hematoma \>=25 cm² * wound hematoma \>=100 cm² * spontaneous nose bleed \>5 min * macroscopic hematuria spontaneous or \>24 hours if associated with an intervention * spontaneous rectal bleeding * gingival bleeding \>5 min * leading to hospitalisation and / or requiring surgical treatment * leading to a transfusion of \<2 units of whole blood or red cells * any other bleeding event considered clinically relevant by the investigator Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above. |
| Number of Participants With Acute Coronary Syndrome (ACS) | From first intake of study drug to last contact date | Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings. |
| Laboratory Analyses | From first intake of study drug to last intake of study drug + 6 days washout | Frequency of patients with possible clinically significant abnormalities. |
| Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE | For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. | Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. |
Countries
Australia, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Hungary, India, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Philippines, Poland, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
There were 2589 patients enrolled/randomised but only 2568 were treated.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran 150 mg bid oral | 1,280 |
| Warfarin PRN to maintain an INR of 2.0-3.0 | 1,288 |
| Total | 2,568 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 47 | 44 |
| Overall Study | Lost to Follow-up | 11 | 6 |
| Overall Study | Other | 4 | 1 |
| Overall Study | Protocol Violation | 31 | 26 |
| Overall Study | Withdrawal by Subject | 32 | 39 |
Baseline characteristics
| Characteristic | Dabigatran 150 mg | Warfarin | Total |
|---|---|---|---|
| Age, Continuous | 54.7 Years STANDARD_DEVIATION 16.19 | 55.1 Years STANDARD_DEVIATION 16.26 | 54.9 Years STANDARD_DEVIATION 16.22 |
| Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE) No PE and no DVT | 1 participants | 1 participants | 2 participants |
| Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE) Symptomatic DVT | 877 participants | 873 participants | 1750 participants |
| Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE) Symptomatic PE | 298 participants | 297 participants | 595 participants |
| Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE) Symptomatic PE and symptomatic DVT | 104 participants | 117 participants | 221 participants |
| Sex: Female, Male Female | 499 Participants | 512 Participants | 1011 Participants |
| Sex: Female, Male Male | 781 Participants | 776 Participants | 1557 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 124 / 1,280 | 126 / 1,288 |
| serious Total, serious adverse events | 156 / 1,280 | 153 / 1,288 |
Outcome results
Primary
Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time frame: For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)
Population: Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 150 mg | Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | Participants with event (up to day 180) | 30 participants |
| Dabigatran 150 mg | Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | Participants with event (up to end of ptp) | 34 participants |
| Warfarin | Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | Participants with event (up to day 180) | 28 participants |
| Warfarin | Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE | Participants with event (up to end of ptp) | 30 participants |
Comparison: Hazard ratio (HR) vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.p-value: 0.000295% CI: [0.69, 1.85]Regression, Cox
Comparison: RD vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.p-value: <0.000195% CI: [-1, 1.3]Kaplan Meier weighted estimates
Comparison: HR vs. Warfarin (events occurring between randomisation and day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE. This analysis was performed as sensitivity analysis for statistical analysis 1.95% CI: [0.64, 1.8]Regression, Cox
Secondary
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities.
Time frame: From first intake of study drug to last intake of study drug + 6 days washout
Population: TS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 150 mg | Laboratory Analyses | AST decrease | 0 participants |
| Dabigatran 150 mg | Laboratory Analyses | ALT increase | 31 participants |
| Dabigatran 150 mg | Laboratory Analyses | ALT decrease | 0 participants |
| Dabigatran 150 mg | Laboratory Analyses | Bilirubin increase | 8 participants |
| Dabigatran 150 mg | Laboratory Analyses | Bilirubin decrease | 0 participants |
| Dabigatran 150 mg | Laboratory Analyses | AST increase | 29 participants |
| Warfarin | Laboratory Analyses | Bilirubin decrease | 0 participants |
| Warfarin | Laboratory Analyses | AST decrease | 0 participants |
| Warfarin | Laboratory Analyses | Bilirubin increase | 6 participants |
| Warfarin | Laboratory Analyses | ALT increase | 40 participants |
| Warfarin | Laboratory Analyses | AST increase | 27 participants |
| Warfarin | Laboratory Analyses | ALT decrease | 0 participants |
Secondary
Number of Participants Who Died (Any Cause)
Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 150 mg | Number of Participants Who Died (Any Cause) | Participants with event (up to day 180) | 25 participants |
| Dabigatran 150 mg | Number of Participants Who Died (Any Cause) | Participants with event (up to end of ptp) | 29 participants |
| Warfarin | Number of Participants Who Died (Any Cause) | Participants with event (up to day 180) | 25 participants |
| Warfarin | Number of Participants Who Died (Any Cause) | Participants with event (up to end of ptp) | 26 participants |
Comparison: RD at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.p-value: 0.734895% CI: [-0.7, 1]Kaplan Meier weighted estimates
Comparison: HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.p-value: 0.893995% CI: [0.61, 1.77]Regression, Cox
Secondary
Number of Participants Who Died Due to VTE
VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events.
Time frame: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 150 mg | Number of Participants Who Died Due to VTE | Participants with event (up to day 180) | 3 participants |
| Dabigatran 150 mg | Number of Participants Who Died Due to VTE | Participants with event (up to end of ptp) | 3 participants |
| Warfarin | Number of Participants Who Died Due to VTE | Participants with event (up to day 180) | 0 participants |
| Warfarin | Number of Participants Who Died Due to VTE | Participants with event (up to end of ptp) | 0 participants |
Comparison: RD at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.p-value: 0.08395% CI: [0, 0.5]Kaplan Meier weighted estimates
Secondary
Number of Participants With Acute Coronary Syndrome (ACS)
Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.
Time frame: From first intake of study drug to last contact date
Population: TS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 150 mg | Number of Participants With Acute Coronary Syndrome (ACS) | During intake of study drug | 3 participants |
| Dabigatran 150 mg | Number of Participants With Acute Coronary Syndrome (ACS) | After stopping study drug | 2 participants |
| Warfarin | Number of Participants With Acute Coronary Syndrome (ACS) | During intake of study drug | 0 participants |
| Warfarin | Number of Participants With Acute Coronary Syndrome (ACS) | After stopping study drug | 1 participants |
Secondary
Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events
Major bleeding events (MBE) are defined as * Fatal bleeding * Symptomatic bleeding in a critical area or organ * Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells Clinically-relevant bleeding events (CRBE) are defined as * spontaneous skin hematoma \>=25 cm² * wound hematoma \>=100 cm² * spontaneous nose bleed \>5 min * macroscopic hematuria spontaneous or \>24 hours if associated with an intervention * spontaneous rectal bleeding * gingival bleeding \>5 min * leading to hospitalisation and / or requiring surgical treatment * leading to a transfusion of \<2 units of whole blood or red cells * any other bleeding event considered clinically relevant by the investigator Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Time frame: From first intake of study drug to last intake of study drug + 6 days washout
Population: Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 150 mg | Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events | MBE | 15 participants |
| Dabigatran 150 mg | Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events | MBE and/or CRBE | 64 participants |
| Dabigatran 150 mg | Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events | Any bleeding event | 200 participants |
| Warfarin | Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events | MBE | 22 participants |
| Warfarin | Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events | MBE and/or CRBE | 102 participants |
| Warfarin | Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events | Any bleeding event | 285 participants |
Comparison: HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of MBE was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.95% CI: [0.36, 1.32]Regression, Cox
Comparison: HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of any bleeding was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.p-value: <0.000195% CI: [0.56, 0.81]Regression, Cox
Secondary
Number of Participants With Recurrent Symptomatic DVT
Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 150 mg | Number of Participants With Recurrent Symptomatic DVT | Participants with event (up to day 180) | 25 participants |
| Dabigatran 150 mg | Number of Participants With Recurrent Symptomatic DVT | Participants with event (up to end of ptp) | 28 participants |
| Warfarin | Number of Participants With Recurrent Symptomatic DVT | Participants with event (up to day 180) | 17 participants |
| Warfarin | Number of Participants With Recurrent Symptomatic DVT | Participants with event (up to end of ptp) | 17 participants |
Comparison: RD vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.p-value: 0.170395% CI: [-0.3, 1.5]Kaplan Meier weighted estimates
Comparison: HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.p-value: 0.105495% CI: [0.9, 3.01]Regression, Cox
Secondary
Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE
Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time frame: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 150 mg | Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE | Participants with event (up to day 180) | 8 participants |
| Dabigatran 150 mg | Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE | Participants with event (up to end of ptp) | 10 participants |
| Warfarin | Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE | Participants with event (up to day 180) | 13 participants |
| Warfarin | Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE | Participants with event (up to end of ptp) | 15 participants |
Comparison: RD vs. Warfarin for Proportion of patients with symptomatic fatal and non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.p-value: 0.32195% CI: [-1, 0.3]Kaplan Meier weighted estimates
Comparison: HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.p-value: 0.302195% CI: [0.29, 1.46]Regression, Cox
Secondary
Number of Participants With Recurrent Symptomatic Non-fatal PE
Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time frame: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 150 mg | Number of Participants With Recurrent Symptomatic Non-fatal PE | Participants with event (up to day 180) | 7 participants |
| Dabigatran 150 mg | Number of Participants With Recurrent Symptomatic Non-fatal PE | Participants with event (up to end of ptp) | 9 participants |
| Warfarin | Number of Participants With Recurrent Symptomatic Non-fatal PE | Participants with event (up to day 180) | 13 participants |
| Warfarin | Number of Participants With Recurrent Symptomatic Non-fatal PE | Participants with event (up to end of ptp) | 15 participants |
Comparison: RD vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.p-value: 0.228395% CI: [-1.1, 0.3]Kaplan Meier weighted estimates
Comparison: HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.p-value: 0.210195% CI: [0.26, 1.35]Regression, Cox
Secondary
Number of Participants With Recurrent Symptomatic VTE and All Deaths
VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 150 mg | Number of Participants With Recurrent Symptomatic VTE and All Deaths | Participants with event (up to day 180) | 51 participants |
| Dabigatran 150 mg | Number of Participants With Recurrent Symptomatic VTE and All Deaths | Participants with event (up to end of ptp) | 57 participants |
| Warfarin | Number of Participants With Recurrent Symptomatic VTE and All Deaths | Participants with event (up to day 180) | 48 participants |
| Warfarin | Number of Participants With Recurrent Symptomatic VTE and All Deaths | Participants with event (up to end of ptp) | 51 participants |
Comparison: RD vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.p-value: 0.693295% CI: [-1.1, 1.6]Kaplan Meier weighted estimates
Comparison: HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.p-value: 0.638395% CI: [0.75, 1.6]Regression, Cox