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 Treatment of Upper Extremity Deep-Vein Thrombosis (NCT00245856), a non-randomized phase 4 study. The primary outcome is Percentage of Participants That Died at 3 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00245856 |
| Phase | Phase 4 |
| Condition | Deep-Vein Thrombosis |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 67 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Oklahoma |
| Results posted | Yes |
2. Clinical Question
Population
Patients diagnosed with upper extremity deep-vein thrombosis and treated for that condition. The registry record reports enrollment of 67 participants.
Intervention
Dalteparin sodium injection, used either as monotherapy or followed by warfarin, according to the treatment description.
Comparator
No randomized comparator is described. The record identifies two treatment patterns, but labels the study nonrandomized and single-group; the patterns should not be read as equivalent control arms.
Primary question
What percentage of participants treated for upper extremity deep-vein thrombosis died by 3 months? The outcome was specified for all treated patients analyzed together.
The study’s stated purpose was to document long-term outcome or prognosis among patients with upper extremity deep-vein thrombosis treated with Fragmin, the brand name included in the study summary for dalteparin sodium injection. The primary endpoint, however, is specifically a percentage of participants who died at 3 months. The registry record does not report a numerical result for that endpoint or its 95% confidence interval.
The clinical question is descriptive rather than a randomized treatment comparison. The treatment description says participants received dalteparin followed by warfarin or dalteparin alone. Because allocation was nonrandomized, differences between these treatment patterns could reflect participant or clinical characteristics as well as treatment. The record does not report a method for adjusting for such differences. Therefore, the described treatment groups do not establish a causal comparison of the strategies.
3. Trial Design
The registry record identifies this as a Phase 4, nonrandomized, unmasked, single-group study of treatment for deep-vein thrombosis. Enrollment was 67. The study sponsor was the University of Oklahoma. The record gives a start date of 2002-09, a primary completion date of 2009-03, and a status of completed.
The brief summary describes documenting long-term outcome or prognosis in patients diagnosed with upper extremity deep-vein thrombosis who were treated with dalteparin sodium injection for three months. The arm description gives two treatment patterns: dalteparin followed by warfarin, or dalteparin monotherapy. The registry’s design labels remain important when interpreting those patterns: allocation is listed as nonrandomized, masking as none, and the model as single-group. They do not constitute randomized, like-for-like control groups.
The primary endpoint is the percentage of participants who died at 3 months, with all treated patients analyzed together. The endpoint is described as having a 95% confidence interval, but its numerical estimate and interval limits are not reported in the registry record. Bleeding events are identified as a secondary outcome. The record lists three outcome measures but does not identify all of them in the available outcome details. It lists no analyses.
The treatment description and primary endpoint establish the broad design and outcome focus, but not the full conduct of the study. The registry record does not report a detailed protocol, eligibility criteria, recruitment process, treatment-selection rationale, follow-up schedule beyond the primary endpoint timeframe, or statistical analysis plan. Those details should not be inferred from the study’s labels or summary.
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.
Before assignment: Consecutive patients, both inpatient and outpatient, who had objectively confirmed upper extremity DVT found on standardized comprehensive duplex imaging or venogram. Ineligibility : predefined ineligibility criteria including high risk of bleeding.
Period One
| Stage | Dalteparin + Warfarin | Dalteparin Only |
|---|---|---|
| STARTED | 28 | 0 |
| COMPLETED | 28 | 0 |
| NOT COMPLETED | 0 | 0 |
Period Two
| Stage | Dalteparin + Warfarin | Dalteparin Only |
|---|---|---|
| STARTED | 0 | 39 |
| COMPLETED | 0 | 38 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Dalteparin + Warfarin | Dalteparin Only |
|---|---|---|
| Withdrawal by Subject | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All DVT treated patients analyzed together
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 | All DVT Treated Patients |
|---|---|---|
| Participants analysed | 67 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 56 |
| Age, Categorical: >=65 years | Participants | 11 |
| Age Continuous | years | 52 (SD 30) |
| Sex: Female, Male: Female | Participants | 36 |
| Sex: Female, Male: Male | Participants | 31 |
| Region of Enrollment: United States | participants | 67 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants That Died at 3 Months, measured over 3 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants who died at 3 months. It is a binary outcome at the participant level: each person either died by the specified time or did not. The registry record states that all treated patients were analyzed together, rather than presenting the primary endpoint as a comparison between the two treatment patterns.
Mortality is a direct outcome that can describe prognosis in a clinical population. Reporting it as a percentage gives a population-level account of how often the event occurred within the specified timeframe. The 3-month timeframe also makes the endpoint interpretable as a defined period after treatment, although the registry record does not describe precisely when follow-up began or how deaths were ascertained.
The stated dispersion measure is a 95% confidence interval. In general, a confidence interval conveys the statistical uncertainty around an estimate; a wider interval indicates less precision than a narrower interval. Here, the registry record does not report either the percentage estimate or the interval limits. Consequently, the endpoint’s observed frequency and precision cannot be assessed from the posted results.
The endpoint should not be confused with a treatment-effect estimate. Since the primary outcome is specified for all treated patients together and the study is nonrandomized, it describes the cohort rather than establishing whether one treatment pattern changes mortality relative to another.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome as the percentage of participants who died at 3 months, analyzed across all treated patients. It specifies a 95% confidence interval as the measure of uncertainty. However, neither the percentage nor the confidence interval limits are reported in the record. The primary result therefore cannot be quantified or assessed for precision from the posted results. No conclusion about the frequency of death in this cohort can be drawn from the endpoint title alone.
The treatment description refers to participants receiving dalteparin followed by warfarin or dalteparin alone. The study is nevertheless labeled nonrandomized and single-group. Treatment-pattern labels do not make the groups exchangeable: when assignment is not random, participant characteristics and clinical decisions can be related to treatment received. The registry record does not report an adjusted analysis to account for such differences. The reported design therefore does not support a causal interpretation of any difference between the treatment patterns.
The adverse-event details list serious events among 28 participants in the Dalteparin + Warfarin group and 39 in the Dalteparin Only group. One participant in each group is listed as affected by a serious event. The record separately lists other events affecting 0 participants in the Dalteparin + Warfarin group and 2 in the Dalteparin Only group. Bleeding is named as the top serious event term, at 3.6%. These figures describe the registry’s recorded event information; they do not establish comparative safety, particularly given the nonrandomized design and the absence of further event definitions and context.
Although the study summary describes an interest in long-term outcome or prognosis, the primary endpoint is set at 3 months. Results for longer-term outcomes are not reported in the registry record. The record also lists three outcome measures but does not identify all their results. These gaps limit how much can be learned from the posted results about outcomes beyond the stated primary measure and the adverse-event entries.
In general, interpretation depends on both the estimated outcome and its uncertainty, as well as the design that generated the data. Here, the missing primary estimate prevents direct assessment of the endpoint, while nonrandom allocation limits any treatment comparison. The record supports a description of the study’s purpose, design labels, endpoint, and recorded adverse-event counts, but not a numerical conclusion about the primary outcome or a causal treatment effect.
9. Statistical Methods Explained
Outcome type and estimate. The primary endpoint is a binary outcome: whether a participant died by 3 months. The planned summary is a percentage of participants, so it describes the proportion of the analyzed population with the event. The primary population is stated as all deep-vein thrombosis treated patients analyzed together. The registry record does not report the observed percentage, event count for this endpoint, or confidence interval limits. The title of an outcome measure is not itself a result.
Confidence intervals. The primary endpoint specifies a 95% confidence interval. In general, a confidence interval expresses uncertainty in an estimate under the statistical method used. It is not a guarantee that the true value lies within a particular calculated interval, nor does it determine whether the result is clinically important. Precision is assessed by the interval’s width, but that cannot be judged because the estimate and interval are not reported. The registry record also does not identify the method used to calculate the interval.
Study design and comparisons. The allocation is labeled nonrandomized, masking is listed as none, and the model is listed as single-group. The arm description nevertheless names dalteparin followed by warfarin and dalteparin monotherapy. These labels describe treatment patterns, not randomized comparison groups. In general, random allocation helps balance measured and unmeasured characteristics across groups. Without it, observed differences may be associated with treatment choice, baseline risk, or other factors. The registry record does not report an adjustment method or other approach to address confounding, so a treatment-effect interpretation is not justified by the design description.
Analysis plan and reported analyses. The record lists no analyses. It does not report the statistical model, a detailed analysis plan, covariate adjustment, subgroup methods, or procedures for estimating the primary endpoint. It also does not report whether any interim analyses were planned or conducted. These matters are not reported in the registry record and should not be inferred. The stated endpoint and its dispersion measure indicate what was intended to be summarized, not the complete analysis procedure.
Planning illustrations. In general, a sample-size calculation can illustrate how many participants per arm might be needed to detect a chosen effect under stated assumptions. Such a calculation is a planning exercise, not an observed result and not a measure of the study’s actual power. The study’s design description is nonrandomized and single-group, while the planning assumptions described in the record refer to equal allocation between two arms and a specified effect fraction. Those assumptions do not describe the study’s allocation. No numerical planning estimates are reported in the registry record, so none can be interpreted as trial enrollment targets or observed power.
Over-dispersion and event data. The primary outcome is binary, and the record does not say that an over-dispersed model was used. In general, over-dispersion means that observed variability exceeds what a model assumes. When present, it can make standard errors too small and confidence intervals too narrow if the model does not account for it. No model diagnostics or adjustment for over-dispersion are reported, so this concept is general statistical context rather than a description of the study’s analysis.
Timeframe and analysis population. The primary endpoint timeframe is 3 months, while the study summary describes an interest in long-term prognosis. The primary endpoint’s specified population is all treated patients analyzed together. The record does not report details about follow-up completeness, censoring, how the time origin was defined, or the handling of participants without outcome information. It therefore does not establish whether the analysis was based on complete follow-up or how incomplete observations were treated.
What can be read from the results. The posted adverse-event information gives counts of participants at risk and affected for serious and other events by treatment pattern, and identifies bleeding at 3.6% as the top serious event term. These are descriptive entries. The registry record does not provide event definitions, exposure-adjusted rates, or a statistical comparison for those entries. In general, event counts alone do not account for differences in follow-up duration or participant characteristics. The lack of randomization further limits comparative interpretation. These method considerations distinguish what is recorded from what would require additional analysis or reporting.
10. Multiplicity, Missing Data and Analysis Populations
The record lists three outcome measures, identifies death at 3 months as the primary endpoint, and names bleeding events as a secondary outcome. It does not identify all three outcome measures in the available outcome details or report results for each. The record lists no analyses. It does not report how many statistical tests were conducted, whether a hierarchy of outcomes was specified, or whether any adjustment for multiple comparisons was planned. In general, testing multiple outcomes can increase the chance of at least one apparently notable result by chance; the appropriate interpretation depends on the prespecified analysis plan. That plan is not reported in the registry record.
Missing-data methods are also not reported. There is no description of the amount or pattern of missing outcome information, how missing observations were handled, or whether sensitivity analyses were conducted. This matters because estimates can be affected when outcome status is unknown, particularly if missingness is related to prognosis or treatment. The primary population is described as all treated patients analyzed together, but the record does not explain whether that population included all enrolled participants for whom outcomes were available.
The record does not report further details about the analysis population, follow-up completeness, or any exclusions from the primary endpoint analysis. Its stated population should therefore be read as the registry’s description, not as evidence about how every participant’s data were handled. These omissions prevent assessment of multiplicity control and the potential impact of missing data on the posted results.
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 |
|---|---|---|---|
| Dalteparin + Warfarin | 1 | 28 | 3.6% |
| Dalteparin Only | 1 | 39 | 2.6% |
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 |
|---|---|
| Dalteparin + Warfarin | 0 of 28 |
| Dalteparin Only | 2 of 39 |
Most frequent serious adverse event terms
| Event term | Organ system | Dalteparin + Warfarin | Dalteparin Only |
|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | 1 of 28 | 1 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dalteparin + Warfarin | Dalteparin Only |
|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | 0 of 28 | 2 of 39 |
Serious events with the highest arm-level rate: bleeding (3.6%).
The serious adverse-event entries list 28 participants at risk in the Dalteparin + Warfarin group, with 1 affected, and 39 at risk in the Dalteparin Only group, with 1 affected. The separate entries for other events list 28 at risk and 0 affected in the Dalteparin + Warfarin group, and 39 at risk and 2 affected in the Dalteparin Only group. Bleeding is identified as the top serious event term at 3.6%.
These entries should be read as descriptive registry figures, not as evidence that one treatment pattern is safer. The groups were not randomized, and the record does not report a statistical comparison, event definitions, timing, severity grading details, or exposure-adjusted rates. It also does not state the count or treatment-group allocation corresponding to the 3.6% bleeding figure. The serious-event counts and the named event term may not answer the same question as an overall comparison of risk.
In general, an event count is most interpretable alongside a clear definition, a denominator, follow-up duration, and information about how events were collected. The registry entries identify participants at risk and affected for the listed categories, but do not provide all of that context. The figures are therefore useful as a limited description of recorded events, not as a basis for causal safety conclusions.
12. What the Result Does, and Does Not, Mean
The record describes a completed Phase 4 study of treatment for upper extremity deep-vein thrombosis. Its primary endpoint was the percentage of treated participants who died at 3 months, with a 95% confidence interval specified. The record does not report the estimate or interval limits, so the primary result’s size and precision cannot be assessed. The study summary’s interest in long-term prognosis does not substitute for reported long-term outcome results; those are not reported in the registry record.
The treatment description includes dalteparin followed by warfarin and dalteparin alone, but the study is labeled nonrandomized and single-group. The treatment patterns should not be treated as randomized arms. In general, nonrandomized comparisons can reflect differences in who received each treatment as well as differences related to treatment itself. The registry record does not report an adjustment strategy that would address this concern. It therefore does not establish whether either pattern caused a better or worse outcome.
The adverse-event entries report serious events affecting 1 participant in each treatment group, and other events affecting 0 participants in the Dalteparin + Warfarin group and 2 in the Dalteparin Only group. Bleeding is listed as the top serious event term at 3.6%. Without further definitions, follow-up context, and a randomized comparison, these entries should remain descriptive rather than be used to infer a difference in safety.
In general, a study result can be informative about the population and outcomes it actually measured, while still leaving uncertainty about precision, comparability, and broader applicability. For this record, enrollment, design labels, treatment patterns, and some adverse-event counts are reported. The numerical primary outcome, detailed analysis methods, and longer-term outcome results are not reported in the registry record. The evidence cannot support a numerical assessment of the primary endpoint or a causal comparison between treatment strategies.
13. Why This Trial Matters Statistically
This study is statistically notable because its clinical question concerns treatment patterns while its design is labeled nonrandomized and single-group. The distinction between a descriptive prognosis study and a causal comparison is central. Treatment groups can be described, but nonrandom allocation means that differences in outcomes cannot automatically be attributed to treatment. The record does not report a method for controlling confounding, so the treatment-pattern labels should not be read as equivalent to randomized arms.
The primary endpoint is clearly named and has a defined timeframe: death at 3 months. It is also assigned a 95% confidence interval as its dispersion measure. Yet the estimate and interval limits are not reported in the registry record. This makes the endpoint statistically difficult to interpret: the outcome definition is available, but neither its observed frequency nor its precision can be evaluated.
The record also illustrates the difference between event listings and comparative safety evidence. Counts are reported for serious and other adverse events in the two treatment patterns, and bleeding is identified at 3.6%. Those entries do not by themselves constitute a formal comparison. Their interpretation depends on definitions, follow-up, and study design, details that are not reported in the registry record.
Finally, the study summary refers to long-term prognosis, whereas the primary endpoint is measured at 3 months. Statistical interpretation must follow the actual outcome timeframe and available results rather than infer unreported longer-term findings. The record’s limitations make it important to separate what is specified from what is numerically reported and to avoid turning a descriptive study into a treatment-effect claim.
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 primary limitation for interpreting the main outcome is that the registry record does not report the percentage of participants who died at 3 months or the 95% confidence interval limits. Without those values, neither event frequency nor precision can be assessed. The record also does not report death counts by treatment pattern; the adverse-event entries do not fill that gap.
The design is labeled nonrandomized, unmasked, and single-group, while the treatment description distinguishes dalteparin followed by warfarin from dalteparin monotherapy. These features limit any comparison between treatment patterns. The record does not report why a treatment pattern was selected, baseline characteristics by pattern, or an adjusted analysis to address possible confounding.
The study summary expresses an interest in long-term outcome or prognosis, but the primary endpoint is at 3 months. Longer-term outcome results and the full set of outcome measures are not reported in the registry record. Follow-up completeness, outcome ascertainment procedures, missing-data handling, eligibility criteria, and analysis-population details are also not reported. These omissions restrict assessment of how representative the analyzed population was and how completely outcomes were observed.
For safety, event definitions and collection procedures are not reported, and the 3.6% bleeding entry is not accompanied by a count or treatment-group allocation. The record also does not report a statistical analysis plan, multiplicity handling, or a method for comparing adverse-event rates. These limitations make the safety entries descriptive and constrain their comparative interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Treatment of Upper Extremity Deep-Vein Thrombosis — NCT00245856.
- Registry record last updated 2013-02-21; status last verified 2013-02.
- Results first posted 2013-02-04.
- 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.
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18. Record Summary
The registry record concerns Treatment of Upper Extremity Deep-Vein Thrombosis, a completed Phase 4 study sponsored by the University of Oklahoma. It reports enrollment of 67 and identifies the design as nonrandomized, unmasked, and single-group. The study summary describes treatment with dalteparin sodium injection, either alone or followed by warfarin, and an interest in long-term prognosis.
The primary endpoint is the percentage of treated participants who died at 3 months, with a 95% confidence interval specified and all treated patients analyzed together. Its numerical result and interval limits are not reported in the registry record. Bleeding events are listed as a secondary outcome. Serious-event entries list 1 affected participant in each treatment pattern, while other-event entries list 0 and 2 affected participants, respectively; bleeding is named as the top serious event term at 3.6%.
The nonrandomized design does not support treating the treatment patterns as randomized controls. Further outcome results, analysis details, missing-data methods, and longer-term findings are not reported in the registry record.