This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE) (NCT00680186), a randomized phase 3 study. The primary outcome is Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00680186 |
| Phase | Phase 3 |
| Condition | Thromboembolism |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 2589 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boehringer Ingelheim |
| Results posted | Yes |
2. Clinical Question
Population
Patients with acute symptomatic venous thromboembolism (VTE), after initial treatment with a parenteral anticoagulant approved for this indication. The registry describes a full analysis set consisting of randomised patients documented to have taken at least one dose of study drug.
Intervention
Oral dabigatran etexilate, 150 mg twice daily. The arm description specifies a capsule containing dabigatran etexilate or matching placebo, taken twice daily.
Comparator
Warfarin, with dosing intended to maintain an international normalised ratio (INR) of 2.0–3.0. The arm description specifies warfarin or matching placebo tablets as needed to maintain the target INR.
Primary question
During six months of treatment, how did dabigatran compare with warfarin for the registry’s primary outcome: recurrent symptomatic VTE and deaths related to VTE?
The trial addressed a comparative efficacy question in a defined treatment setting: acute symptomatic VTE following an initial course of parenteral anticoagulation. It compared two oral treatment strategies, with dabigatran given twice daily and warfarin adjusted to a target INR. The registry describes the study as randomised, double blind, and parallel group, which sets the design context for interpreting a between-group comparison.
The primary outcome’s title combines recurrent symptomatic VTE with deaths related to VTE. The description says suspected recurrent VTEs, deaths, and bleeding events were evaluated by an independent central adjudication committee, and that analyses were based on events centrally confirmed by that committee. However, the registry record does not report the component-specific primary outcome results or an overall comparative estimate. It therefore does not establish from the information how the groups compared on that endpoint.
The registry lists a planned six-month treatment period and an initial parenteral treatment period of 5–10 days. One primary analysis timeframe runs from randomisation to the end of the post-treatment period, planned to be up to day 224; another runs from randomisation to six months, up to day 180. These are distinct analysis windows, so an estimate for one window should not automatically be treated as an estimate for the other. Numerical primary-outcome results and their uncertainty are not reported in the registry record.
3. Trial Design
The registry describes a Phase III, randomised, double-blind, parallel-group study sponsored by Boehringer Ingelheim. Its recorded enrollment is 2589. The comparison was between oral dabigatran etexilate and warfarin for treatment of acute symptomatic VTE, after initial treatment with an approved parenteral anticoagulant. The planned treatment duration was six months.
The dabigatran arm used 150 mg twice daily. The warfarin arm aimed to maintain an INR of 2.0–3.0, with tablets described as being taken as needed to reach that target. The arm descriptions also mention matching placebo. The registry’s general study summary describes the warfarin approach as PRN, or as needed, to maintain the target INR. Details of how treatment blinding was operationalised are not reported in the registry record.
Random allocation is intended, in general, to make treatment groups comparable with respect to measured and unmeasured baseline characteristics on average. Double masking is intended, in general, to reduce the influence of treatment knowledge on care, participant experience, and outcome assessment. These design features support a fair comparison, but they do not by themselves show the size, precision, or clinical interpretation of a treatment contrast. Those depend on the observed outcomes, analysis methods, and follow-up.
The primary endpoint description identifies a full analysis set: all randomised patients documented to have taken at least one dose of study drug, analysed according to their randomised groups regardless of the medication actually taken. This definition is narrower than simply saying everyone enrolled was analysed, and it specifies how treatment assignment was handled within that population. A separate safety analysis population definition is not reported in the registry record, although adverse-event counts are listed by group.
The registry gives two primary analysis timeframes. One extends from randomisation to the end of the post-treatment period, planned to be up to day 224. The other extends from randomisation to six months, up to day 180. The primary outcome is not reduced in the record to one comparison because it has several categories or time points. The registry record does not report the protocol’s detailed statistical plan, the rationale for the enrollment target, or whether interim analyses were planned.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Dabigatran 150 mg | Warfarin |
|---|---|---|
| STARTED | 1280 | 1288 |
| COMPLETED | 1155 | 1172 |
| NOT COMPLETED | 125 | 116 |
Reasons for not completing this period:
| Reason | Dabigatran 150 mg | Warfarin |
|---|---|---|
| Adverse Event | 47 | 44 |
| Protocol Violation | 31 | 26 |
| Lost to Follow-up | 11 | 6 |
| Withdrawal by Subject | 32 | 39 |
| Other | 4 | 1 |
Analysis population for the primary outcome, as defined in the registry: 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.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Dabigatran 150 mg | Warfarin | Total |
|---|---|---|---|---|
| Participants analysed | 1280 | 1288 | 2568 | |
| Age, Continuous | Years | 54.7 (SD 16.19) | 55.1 (SD 16.26) | 54.9 (SD 16.22) |
| Sex: Female, Male: Female | Participants | 499 | 512 | 1011 |
| Sex: Female, Male: Male | Participants | 781 | 776 | 1557 |
| Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE): Symptomatic PE and symptomatic DVT | participants | 104 | 117 | 221 |
| Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE): Symptomatic PE | participants | 298 | 297 | 595 |
| Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE): Symptomatic DVT | participants | 877 | 873 | 1750 |
| Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE): No PE and no DVT | participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE, measured over 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).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled number of participants with recurrent symptomatic VTE and deaths related to VTE. It is described as a count of participants, and the registry identifies the outcome type as binary, meaning that the concept is whether a participant had an event rather than a continuous measurement such as a laboratory value. The endpoint combines recurrent symptomatic VTE with deaths related to VTE; separate component results are not reported in the registry record.
In general, a composite endpoint can capture more than one clinically relevant way an outcome may occur. Its interpretation depends on the component definitions and on how frequently each component occurs. A combined result does not necessarily describe each component equally well: a reader needs component-specific results to assess whether the overall finding reflects recurrent VTE, VTE-related death, or both. Those component counts and comparative estimates are not reported in the registry record.
The registry states that suspected recurrent VTEs, deaths, and bleeding events were reviewed by an independent central adjudication committee, and that analyses used centrally confirmed events. In general, central adjudication can apply common criteria across treatment groups, helping make outcome classification more consistent. The primary outcome has two listed timeframes: randomisation to the end of the post-treatment period, planned to be up to day 224, and randomisation to six months, up to day 180. Results for either timeframe are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically focused comparison: dabigatran etexilate versus warfarin for acute symptomatic VTE after initial parenteral anticoagulation. Its primary endpoint concerns recurrent symptomatic VTE and deaths related to VTE. The design is described as randomised, double blind, and parallel group, and the primary analysis population is defined according to randomised assignment among those documented to have taken at least one dose.
Those design details explain what the trial set out to compare, but they are not themselves evidence of the direction or magnitude of the outcome. Primary endpoint counts, a treatment-effect estimate, a confidence interval, and a p-value are not reported in the registry record. Without those results, the relative frequency of the primary endpoint between groups cannot be characterized from the registry information. No conclusion about whether one strategy had more or fewer primary endpoint events is supported by these details alone.
The endpoint is described as a participant count and as binary. In general, binary outcome analyses compare the proportion of participants with an event between groups, or use another prespecified measure of the contrast. The choice of measure matters: a risk difference, risk ratio, or odds ratio has a different scale and interpretation. The registry record does not report a primary effect estimate or specify a reported measure for this comparison. No unreported contrast should be reconstructed from the enrollment figure or the safety counts.
The two timeframes also matter. One analysis runs from randomisation through the end of the post-treatment period, planned to be up to day 224; another runs from randomisation to six months, up to day 180. In general, estimates over different follow-up windows answer different questions because events occurring after one window’s cutoff may be counted in another. The registry record does not report the primary outcome estimates for either window, so the time-specific findings cannot be compared.
The adverse-event figures are separate from the primary efficacy endpoint. The record lists serious adverse events and other adverse events by treatment group, with participants at risk and participants affected. Those counts can describe the recorded safety experience, but they do not supply the missing primary efficacy comparison. Nor should counts alone be treated as a complete account of event timing, severity, duration, or causal relationship.
For statistical precision, a point estimate is usually read alongside a confidence interval. In general, a confidence interval expresses the range of values reasonably compatible with the data under the analysis assumptions; it is not a guarantee that the true value lies within a particular interval. No interval for the primary endpoint is reported in the registry record. Thus neither the size of any difference nor its precision can be assessed from the endpoint information available.
9. Statistical Methods Explained
The registry describes a randomised, double-blind, parallel-group design. In general, randomisation assigns participants to treatment groups using a chance-based process. This can reduce systematic differences between groups at the start of a study, although chance imbalances can still occur. Masking means that treatment assignment is concealed from specified people involved in the study; the registry labels the study double blind but does not report detailed operational arrangements. A parallel-group design means participants are assigned to a group and compared across groups rather than being described as crossing between treatments.
What does a binary participant outcome mean?
The primary outcome is a number of participants with recurrent symptomatic VTE and deaths related to VTE, and the registry classifies it as binary. In general, a binary outcome records whether each participant experienced the event under the outcome definition. A group-level analysis can then compare the proportion with an event or use another effect measure selected by the statistical plan. The registry record does not report the primary outcome counts or a treatment-effect estimate, and it does not identify a reported measure for the primary comparison.
A count of participants with an event is not the same as a count of every event. If one participant can have more than one event, participant-based and event-based summaries answer different questions. The endpoint is named as participants with the outcome, while the analysis description says suspected recurrent VTEs and deaths were centrally adjudicated. The registry record does not report further details on how multiple events in one participant were handled in the primary analysis.
Why does adjudication matter?
The registry says an independent central adjudication committee evaluated suspected recurrent VTEs, deaths, and bleeding events, and that analyses were based on centrally confirmed events. In general, adjudication applies defined review procedures to determine whether a suspected event meets the study’s criteria. Central review may help maintain consistent classification across groups. It does not, on its own, establish that every possible event was detected or that the analysis is free from other sources of bias. The detailed adjudication criteria are not reported in the registry record.
How should the analysis population be understood?
The full analysis set consists of all randomised patients documented to have taken at least one dose of study drug. Participants remain assigned to their randomised treatment groups for analysis, regardless of the medication actually taken. In general, analysing participants according to randomised assignment preserves the comparison created by randomisation better than regrouping them according to treatment received. The stated full analysis set nevertheless requires at least one dose, so it should not be casually equated with every person enrolled or every person randomised. The registry record does not report the number excluded from this set or the reasons for any exclusions.
What do the two timeframes imply?
The registry lists one primary analysis from randomisation to the end of the post-treatment period, planned to be up to day 224, and another from randomisation to six months, up to day 180. In general, an outcome window defines which events count for a particular analysis. A longer or differently defined observation window can include events not included in another window. The two analyses should therefore be treated as distinct rather than interchangeable. Their results and any explanation of how follow-up was handled are not reported in the registry record.
For time-to-event data, general methods can account for the timing of events and for participants whose event status is not observed through the full follow-up period. The primary endpoint is described as a participant count and binary outcome, not as a reported time-to-event estimate. The registry record does not report a survival model, hazard ratio, censoring method, or other time-to-event analysis for this endpoint. It would be inappropriate to assume one solely from the existence of follow-up windows.
What do confidence intervals and significance tests contribute?
In general, a confidence interval communicates statistical uncertainty around an estimate. A narrow interval indicates greater precision than a wide interval under the same analysis assumptions, while the interval’s location indicates which values are compatible with the data. A significance test addresses a specified null hypothesis using a test statistic and a decision threshold. Neither a confidence interval nor a p-value tells the whole story: the magnitude and clinical meaning of an estimate also matter. The registry record does not report a confidence interval or p-value for the primary endpoint.
The registry’s planning description refers to a two-sided significance level of 0.05, equal allocation, and a normal approximation for sample-size illustrations based on a stated fraction of the observed effect. In general, such illustrations ask how many participants per arm would be required under stated assumptions to detect a chosen effect with a chosen power. The registry record does not report numerical planning-illustration values in the registry record, and those calculations are not observed power. They should not be confused with evidence about the trial’s actual results or with the original design justification, which is not reported in the registry record.
What analysis details remain unknown?
The registry record does not report the primary model, covariate adjustment, handling of missing outcome data, or the detailed inferential procedure. It also does not report a statistical analysis plan or whether analyses were prespecified beyond the endpoint and timeframes listed. These details can affect both the estimate and its uncertainty. Without them, the design and endpoint description can be explained, but a full independent reconstruction of the primary analysis is not possible.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome with more than one analysis timeframe: from randomisation to the end of the post-treatment period, planned to be up to day 224, and from randomisation to six months, up to day 180. It also lists secondary outcomes including recurrent symptomatic VTE and all deaths, recurrent symptomatic deep vein thrombosis, recurrent symptomatic non-fatal pulmonary embolism, VTE-related death, death from any cause, pulmonary embolism, bleeding outcomes, and acute coronary syndrome. The record notes 10 outcome measures and 16 analyses.
In general, testing multiple outcomes, timeframes, or comparisons can increase the chance of at least one apparently positive result when all null hypotheses are true. Statistical plans may address this through a hierarchy, adjustment, or a clear distinction between confirmatory and exploratory analyses. The registry record does not report a multiplicity-control strategy, an ordering of hypotheses, or which secondary analyses were confirmatory. The count of listed outcomes and analyses alone does not show how multiplicity was handled.
The registry defines the full analysis set as randomised patients documented to have taken at least one dose, analysed as randomised. It does not report how missing outcome information was handled, whether any imputation was used, or how participants with incomplete follow-up were treated. Those details are important because missingness can affect the estimated event frequency and the validity of group comparisons. The number of participants with missing primary endpoint data and reasons for missingness are not reported in the registry record.
The registry record also does not report the statistical analysis plan, protocol details about interim analyses, or an explanation of the relationship between the listed analyses and any multiplicity strategy. These omissions limit assessment of whether the reported comparisons, if available, followed prespecified procedures. They do not establish that a particular method was or was not used; they mean the method is not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Dabigatran 150 mg | 156 | 1280 | 12.2% |
| Warfarin | 153 | 1288 | 11.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Dabigatran 150 mg | 124 of 1280 |
| Warfarin | 126 of 1288 |
Most frequent serious adverse event terms
| Event term | Organ system | Dabigatran 150 mg | Warfarin |
|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 14 of 1280 | 9 of 1288 |
| Deep vein thrombosis | Vascular disorders | 13 of 1280 | 8 of 1288 |
| Pneumonia | Infections and infestations | 9 of 1280 | 4 of 1288 |
| Chest pain | General disorders | 7 of 1280 | 5 of 1288 |
| Haematuria | Renal and urinary disorders | 3 of 1280 | 9 of 1288 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 3 of 1280 | 8 of 1288 |
| Cellulitis | Infections and infestations | 5 of 1280 | 4 of 1288 |
| Sepsis | Infections and infestations | 3 of 1280 | 4 of 1288 |
| Urinary tract infection | Infections and infestations | 3 of 1280 | 4 of 1288 |
| Anaemia | Blood and lymphatic system disorders | 3 of 1280 | 2 of 1288 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dabigatran 150 mg | Warfarin |
|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 75 of 1280 | 69 of 1288 |
| Headache | Nervous system disorders | 57 of 1280 | 70 of 1288 |
Serious events with the highest arm-level rate: pulmonary embolism (1.1%), deep vein thrombosis (1.0%), pneumonia (0.7%), haematuria (0.7%), dyspnoea (0.6%).
The registry lists serious adverse-event counts by group. For dabigatran 150 mg, 1280 participants were at risk and 156 were affected. For warfarin, 1288 participants were at risk and 153 were affected. It separately lists other adverse-event counts: 124 affected among 1280 at risk in the dabigatran group, and 126 affected among 1288 at risk in the warfarin group. These are registry counts, not a complete description of event timing or severity.
In general, an affected-participant count indicates how many participants were recorded with an event under the category’s definition; it does not indicate the number of all event episodes if participants could experience more than one. The registry record does not give further details about event duration, recurrence, seriousness criteria, or the attribution of each event to study treatment. The counts should therefore be read as descriptive safety information rather than as a causal comparison.
The registry also lists serious-event terms with percentages: pulmonary embolism, 1.1%; deep vein thrombosis, 1.0%; pneumonia, 0.7%; haematuria, 0.7%; dyspnoea, 0.6%; and chest pain, 0.5%. The record does not report which treatment group each percentage refers to in this list. These terms should not be assigned to either group or treated as arm-specific comparative estimates. Safety figures do not replace the primary efficacy outcome, whose numerical results are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study question, treatment strategies, design labels, endpoint definition, analysis population, and some adverse-event counts. It describes a randomised, double-blind, parallel-group comparison of dabigatran etexilate and warfarin for acute symptomatic VTE, with an intended six-month treatment period after initial parenteral treatment. It also states that primary suspected events were centrally adjudicated and identifies two primary analysis windows.
These registry entries do not give the primary endpoint result. The record does not report the number of participants with recurrent symptomatic VTE and deaths related to VTE in either group, a comparative estimate, a confidence interval, or a p-value. Consequently, it is not possible to determine from these registry entries whether the groups differed on the primary endpoint, how large any difference was, or how precisely it was estimated. The absence of a reported estimate is not evidence that the groups were the same.
The safety counts describe participants affected by serious and other adverse events in each arm. They do not, on their own, establish that a treatment caused an event or that one treatment had a safer overall profile. In general, causal interpretation requires attention to the study design, the event definitions, the completeness of follow-up, the analysis population, and uncertainty around the comparison. The registry record does not provide a comparative safety analysis or uncertainty estimates for these counts.
The endpoint combines recurrent symptomatic VTE and deaths related to VTE. In general, a combined endpoint can be useful for assessing more than one relevant event type, but its overall estimate can conceal variation among components. Component-specific results would help clarify what contributed to any composite result; those results are not reported in the registry record. The record likewise does not report details needed to assess missing data, multiplicity, or the full statistical model.
Accordingly, the information supports a description of the trial’s design and recorded safety counts, but not a conclusion about comparative efficacy or a definitive treatment benefit or harm. A statistical interpretation of the primary comparison would require the actual outcome estimates and their uncertainty, along with relevant analysis details. No medical recommendation follows from the registry entries alone.
13. Why This Trial Matters Statistically
This trial is statistically notable for comparing two treatment strategies in a randomised, double-blind, parallel-group design while defining a specific participant-based primary endpoint. The registry’s endpoint combines recurrent symptomatic VTE with deaths related to VTE, and it describes central adjudication of suspected VTEs, deaths, and bleeding events. These features make clear what event classification and treatment contrast the study intended to examine.
The primary analysis population is also explicitly described. It includes randomised patients documented to have taken at least one dose and retains randomised group assignment regardless of medication actually taken. In general, stating the analysis population and assignment rule is important because different population definitions can yield different estimates and may preserve the original randomised comparison to different degrees.
The registry lists two timeframes for the primary outcome, one extending to the end of the post-treatment period, planned to be up to day 224, and another to six months, up to day 180. This highlights a basic statistical issue: an outcome estimate is tied to its follow-up window. Two analyses of the same event definition can answer different questions when their observation periods differ.
The record also illustrates why design descriptions must be separated from outcome evidence. Randomisation, masking, and adjudication explain safeguards in the study process; they do not substitute for a reported estimate, interval, and analysis plan. Because the primary numerical comparison and its uncertainty are not reported in the registry record, statistical conclusions about the treatment contrast cannot be drawn from the design information alone. The listed safety counts provide descriptive information, but likewise do not establish a comparative effect.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation of the registry information is that numerical primary endpoint results are not reported. The primary outcome is described, but there are no group-specific event counts, treatment-effect estimate, confidence interval, or p-value in the record details. This prevents assessment of both the direction and precision of the primary comparison.
The endpoint is a composite of recurrent symptomatic VTE and deaths related to VTE, but component-specific results are not reported in the registry record. The description identifies central adjudication but does not provide the detailed event criteria or explain how multiple events in a participant were handled. The two analysis windows are identified, but results for either window are not reported.
Important analysis details are also absent. The registry record does not report the primary statistical model, covariate adjustment, missing-data methods, multiplicity strategy, or a detailed statistical analysis plan. It does not report whether interim analyses were planned or provide the protocol’s sample-size justification. The planning description refers to illustrations based on the observed effect, but numerical illustration results are not reported in the registry record and should not be mistaken for observed power.
Safety information is limited to participant counts by group and a list of serious-event terms with percentages. The record does not specify the group attribution for the listed percentages, nor does it give detailed event timing, duration, or treatment attribution in the registry record. These limitations mean that the registry entries support a careful account of design and recorded counts, but not a complete independent evaluation of efficacy, safety, or the statistical analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE) — NCT00680186.
- Registry record last updated 2014-05-19; status last verified 2013-12.
- Results first posted 2012-06-14.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry describes NCT00680186 as a completed Phase III, randomised, double-blind, parallel-group study sponsored by Boehringer Ingelheim. Recorded enrollment is 2589. It compared oral dabigatran etexilate 150 mg twice daily with warfarin targeted to an INR of 2.0–3.0 for six-month treatment of acute symptomatic VTE after initial parenteral anticoagulation.
The primary outcome was recurrent symptomatic VTE and deaths related to VTE, evaluated using centrally confirmed events. The full analysis set included randomised patients documented to have taken at least one dose, analysed according to randomised assignment. Two primary analysis timeframes are listed: through the post-treatment period, planned to be up to day 224, and through six months, up to day 180.
Group-specific primary outcome results and their uncertainty are not reported in the registry record. Serious and other adverse-event participant counts are listed by group, along with serious-event terms and percentages whose group attribution is not reported.