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 A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) (NCT00619099), a randomized phase 2 study. The primary outcome is The Overall Improvement Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00619099 |
| Phase | Phase 2 |
| Condition | Myelodysplastic Syndrome |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 67 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eisai Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Adults with myelodysplastic syndromes classified as low or intermediate-1 risk. The primary outcome was specified for a modified intent-to-treat population, but the registry record does not define that population or give its size.
Intervention
Decitabine given subcutaneously on Schedule A: three consecutive days. The registry record does not state the dose amount or provide a fuller schedule description.
Comparator
Decitabine given subcutaneously on Schedule B: once every seven days. Both study arms used decitabine; the comparison was between schedules, not between decitabine and an untreated or different-drug group.
Primary question
What overall improvement rate was observed with each schedule, using complete remission, partial remission, marrow complete remission, or hematologic improvement as qualifying responses during follow-up of up to one year? The registry record does not report a numerical result or a direct statistical comparison for this outcome.
The study was intended to assess the effectiveness and safety of two decitabine schedules in people with myelodysplastic syndromes. Its central statistical question is therefore comparative: whether the proportion meeting the registry’s response definition differed between the schedules. Random allocation is relevant to that comparison because, in general, it is intended to make treatment groups comparable at the point of assignment. The record does not include enough information to assess how allocation was carried out or whether the groups were balanced on particular characteristics.
The primary outcome combines several forms of improvement into one overall response concept. That can offer a broad measure of response, but it also means that a single overall proportion does not show which response category contributed to the result. The registry record names complete remission, partial remission, marrow complete remission, and hematologic improvement as qualifying categories. It does not report their separate counts or the overall improvement rates by schedule.
Accordingly, the intended question can be identified, but the posted results do not answer it numerically. There is no reported estimate of the difference between schedules, no uncertainty interval, and no reported significance test for the primary outcome in the registry record. The available information supports a description of the design and endpoint, not a conclusion about which schedule had a higher response rate.
3. Trial Design
This was a randomized, open-label, parallel-group phase 2 study of decitabine in patients with low or intermediate-1 risk myelodysplastic syndromes. The registry lists enrollment of 67. The study began in 2008-05, reached primary completion in 2012-03, and has completed status. Eisai Inc. is listed as the sponsor.
The two groups differed in their subcutaneous dosing schedules. Schedule A is described as three consecutive days; Schedule B is described as once every seven days. Both interventions are listed as decitabine. The registry does not provide dose amounts or fuller descriptions of either arm, so the schedule titles are the extent of the regimen detail that can be stated from this record.
Randomization means that participants are assigned to groups by a chance-based process, in general. Its purpose is to reduce systematic differences between groups at assignment, though it does not guarantee identical groups, especially in a study of limited size. The registry identifies the study as randomized but does not report the allocation method, allocation concealment, or any details that would allow those procedures to be assessed.
The study was open-label, meaning masking was not used according to the registry. In general, knowledge of the assigned schedule can affect care, reporting, or assessment. The record does not explain what safeguards, if any, were used to limit those influences. A parallel design means the assigned groups were followed as separate groups rather than participants switching between schedules, but the registry does not give further details about follow-up or treatment duration.
The primary outcome timeframe is up to one year. The outcome is defined for a modified intent-to-treat population, while the registry enrollment figure is 67; the record does not explain the relationship between enrollment and the analysis population or provide its size. It also does not report the planned sample-size justification, a detailed statistical analysis plan, or whether interim analyses were planned or conducted.
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 | Schedule A: SQ 3 Consecutive Days | Schedule B: SQ Once Every 7 Days |
|---|---|---|
| STARTED | 44 | 23 |
| Received at Least 2 Cycles of Treatment | 43 | 22 |
| COMPLETED | 11 | 4 |
| NOT COMPLETED | 33 | 19 |
Reasons for not completing this period:
| Reason | Schedule A: SQ 3 Consecutive Days | Schedule B: SQ Once Every 7 Days |
|---|---|---|
| Progressive Disease | 7 | 5 |
| Allogeneic Bone Marrow Transplantation | 2 | 1 |
| Adverse Event | 4 | 3 |
| Emergence of Clinically Significant Lab | 1 | 2 |
| Withdrawal by Subject | 10 | 2 |
| Physician Decision | 9 | 6 |
Analysis population for the primary outcome, as defined in the registry: Modified Intent to Treat (mITT) Population
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.
Population: Modified Intent to Treat (mITT) Population
| Characteristic | Unit | Schedule A: SQ 3 Consecutive Days | Schedule B: SQ Once Every 7 Days | Total |
|---|---|---|---|---|
| Participants analysed | 43 | 22 | 65 | |
| Age Continuous | years | 66.9 (SD 14.39) | 70.5 (SD 9.86) | 68.2 (SD 13.07) |
| Sex: Female, Male: Female | Participants | 18 | 2 | 20 |
| Sex: Female, Male: Male | Participants | 25 | 20 | 45 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 2 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 42 | 20 | 62 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 0 | 5 |
| Race (NIH/OMB): White | Participants | 35 | 20 | 55 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as The Overall Improvement Rate, measured over Up to one year.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the overall improvement rate, expressed as the percentage of participants who had one or more qualifying responses: complete remission, partial remission, marrow complete remission, or hematologic improvement. The timeframe is up to one year, and the stated population is the modified intent-to-treat population. The definition refers to Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.
In general, a binary response endpoint classifies each participant as meeting or not meeting a specified response definition. The overall rate describes the proportion classified as responders. Combining response categories can capture several ways in which disease measures may improve, rather than requiring every responder to meet the same category. However, the overall rate does not by itself show the mix of response types or the degree of change within each type.
The registry gives descriptions of the response categories. Complete remission includes bone marrow and peripheral blood criteria. Partial remission uses the complete-remission criteria with an exception involving the marrow blast response. Marrow complete remission is based on marrow findings, with any hematologic improvement noted as well. Hematologic improvement is described through increases in hemoglobin, platelet, and neutrophil response. The precise criteria are stated in the registry record.
This endpoint is suitable for a schedule comparison only if its definition and assessment are applied consistently to both groups. In general, a reported percentage should be interpreted alongside the number assessed and a measure of uncertainty. The registry record does not report the overall improvement rate, group-specific response counts, confidence intervals, or a comparative estimate. Thus the endpoint’s intended meaning is clear, but its observed result cannot be described from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a randomized comparison of two subcutaneous decitabine schedules, with overall improvement as the primary outcome. It does not provide a numerical primary-outcome result for either schedule. In particular, no response percentage, group-specific responder count, difference between schedules, confidence interval, or p-value is reported for the primary endpoint. The posted information therefore does not establish the direction or size of any difference in overall improvement.
The endpoint combines complete remission, partial remission, marrow complete remission, and hematologic improvement. This combined definition answers whether participants met at least one listed response category, but it does not reveal which categories occurred or how often. Separate results for the component categories are not reported in the registry record. Nor does the record give the number of participants included in the modified intent-to-treat population for this outcome.
The study enrolled 67 participants, but enrollment should not be treated as the denominator for the primary outcome without a reported analysis population and outcome counts. The record identifies a modified intent-to-treat population but does not define its membership, state how missing assessments were handled, or provide the number evaluated. Those omissions prevent reconstruction of the response proportions from the information available.
Safety information is reported separately. The adverse-event listing gives counts of participants with serious adverse events and other adverse events in each schedule group, along with selected serious-event terms and percentages. These figures describe events recorded in the registry; they are not a substitute for the missing primary response results and do not establish a comparative benefit-risk conclusion. The registry does not report death counts.
In general, a point estimate describes the observed result in the participants analyzed, while a confidence interval communicates the uncertainty around that estimate. A statistical test addresses how compatible the data are with a specified null hypothesis under its assumptions. Neither type of inferential result can be interpreted for the primary outcome because no estimate, interval, or test result is reported.
Randomization is a useful design feature for comparing schedules, but it does not by itself supply evidence about the outcome. Interpretation still depends on observed results, an adequately described analysis population, complete follow-up, and appropriate methods. Those elements are not all available in the registry record. The appropriate reading is therefore limited: the study’s comparative objective and endpoint are stated, but the posted results do not show which schedule had a higher overall improvement rate or how precisely that rate was estimated.
9. Statistical Methods Explained
The registry identifies a randomized, open-label, parallel phase 2 design and a binary primary outcome. These labels describe different aspects of the study: how participants were assigned, whether masking was used, how groups were followed, and what kind of outcome was measured. They do not, by themselves, describe the statistical analysis in detail. No primary-outcome analysis is reported in the registry record.
What does a binary percentage represent?
In general, a binary outcome places each participant into one of two states for the analysis: meeting the response definition or not meeting it. The response percentage is based on the number who meet the definition relative to the analysis denominator. For this study, qualifying response categories are complete remission, partial remission, marrow complete remission, and hematologic improvement. The registry does not give the numbers in either outcome state by schedule, or the denominator used for either group.
When results are available, a percentage is easiest to interpret alongside its numerator and denominator. The numerator indicates how many participants met the endpoint, while the denominator indicates how many participants contributed to that estimate. The same percentage can have different precision depending on how many participants were assessed. Since neither the primary response counts nor the modified intent-to-treat population size is reported, readers cannot assess those features for this endpoint.
How would a schedule comparison be expressed?
In general, a comparison of two binary outcomes can be expressed using the response proportion in each group and a contrast between groups. Common contrasts include a difference between proportions or a ratio of proportions. These answer different questions and should not be treated as interchangeable. The selected contrast, its confidence interval, and any statistical test should be reported as part of the analysis. The registry record does not report a primary-outcome contrast or identify a test used for it.
A confidence interval gives a range of values compatible with the data under the method’s assumptions and indicates how uncertain the estimate is. A narrow interval generally conveys greater precision than a wide interval. It does not show whether the study was well designed or whether the endpoint is clinically important; those questions require other information. No confidence interval for the primary outcome is reported.
A p-value, when used, summarizes how unusual the observed data would be under a specified null hypothesis and statistical model. It does not measure the probability that the null hypothesis is true, nor does it measure the size or importance of an effect. No primary-outcome p-value is reported. The absence of a reported p-value should not be interpreted as evidence that the schedules were equivalent.
What does randomization contribute?
In general, random assignment is intended to distribute both measured and unmeasured prognostic factors across study groups without systematic selection. It supports a fair comparison when the assigned groups are analyzed appropriately and outcome assessment is sufficiently complete. Randomization does not prevent chance imbalances, and it cannot correct problems such as differential loss to follow-up or inconsistent outcome assessment. The record identifies randomization but does not report its procedure or describe baseline balance.
The open-label designation means masking was not used. In general, awareness of the assigned schedule can influence decisions or assessments, especially when outcomes involve judgment. The endpoint uses named response criteria, but the registry does not say who assessed responses, whether assessment was independent, or whether any review process was used. Those details are not reported in the registry record.
Why does the analysis population matter?
The primary outcome is assigned to a modified intent-to-treat population. In general, intent-to-treat approaches seek to preserve the advantages of randomization by analyzing participants according to their assigned group. A modified population may use additional eligibility or assessment rules, but the meaning varies by study. The registry does not define the modification, state which participants were included or excluded, or give the population size. It is therefore not possible to determine how closely the primary analysis reflects all randomized participants.
Missing outcome data can affect a response percentage if participants without an assessment are excluded or classified in another way. In general, the handling method should be specified because different choices can change the estimate and its uncertainty. The registry record does not report the amount of missing primary-outcome data or the method used to handle it. It also does not report a sensitivity analysis addressing missing outcomes.
What can planning illustrations tell readers?
Sample-size calculations are planning exercises based on assumptions about the effect to detect, the significance level, allocation, and statistical model. They are not observed trial outcomes and do not establish that a study was adequately powered after the fact. The registry record does not report the study’s own sample-size justification. No observed primary effect is available in the posted results from which to interpret a planning illustration as a comparison of the schedules. Any planning values should therefore be read as conditional illustrations, not as evidence of an observed treatment effect or as observed power.
More broadly, the registry’s stated endpoint, design labels, and adverse-event counts do not constitute a complete statistical report. A full interpretation of a binary endpoint would ordinarily need the analysis denominator, response counts, an estimate of the between-group contrast, uncertainty, and a clear account of the analysis population and missing data. Those primary-outcome details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint combines several response categories: complete remission, partial remission, marrow complete remission, and hematologic improvement. That makes the overall rate a composite response measure. The registry record does not report separate statistical results for those component categories, so it is not possible to assess whether one category drove an overall finding.
The record lists no analyses for the primary outcome and does not report a statistical analysis plan or a multiplicity strategy. In general, multiplicity arises when several outcomes, comparisons, time points, or subgroups are tested; repeated testing can increase the chance of at least one apparently unusual result. A prespecified approach can clarify which analyses are primary and how additional tests should be interpreted. The registry record does not describe such an approach. This does not establish that multiplicity was mishandled; it means the approach is not reported.
The primary outcome is defined for a modified intent-to-treat population, but that population is not defined or sized in the registry record. The record does not report how participants were selected for that analysis, whether participants were analyzed according to randomized assignment, or whether any participants were excluded after assignment. Enrollment of 67 alone does not identify the primary-outcome denominator.
Missing-data handling is also not reported. The record does not state how many participants lacked an evaluable response, how missing assessments were classified, or whether sensitivity analyses were conducted. In general, these choices matter because the estimated response rate depends on which participants are included and how unavailable outcomes are treated. Without those details, the primary outcome cannot be independently reconstructed or its robustness assessed.
The registry record also does not report interim analyses or stopping rules. Their presence or absence cannot be inferred from the completed status. Overall, the main statistical limitations are incomplete reporting of the analysis population, outcome data, missing-data approach, and plans for multiple analyses.
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 |
|---|---|---|---|
| Schedule A: SQ 3 Consecutive Days | 18 | 43 | 41.9% |
| Schedule B: SQ Once Every 7 Days | 10 | 22 | 45.5% |
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 |
|---|---|
| Schedule A: SQ 3 Consecutive Days | 43 of 43 |
| Schedule B: SQ Once Every 7 Days | 22 of 22 |
Most frequent serious adverse event terms
| Event term | Organ system | Schedule A: SQ 3 Consecutive Days | Schedule B: SQ Once Every 7 Days |
|---|---|---|---|
| Pneumonia | Infections and infestations | 1 of 43 | 2 of 22 |
| Febrile neutropenia | Blood and lymphatic system disorders | 2 of 43 | 0 of 22 |
| Cellulitis | Infections and infestations | 1 of 43 | 1 of 22 |
| Dehydration | Metabolism and nutrition disorders | 1 of 43 | 1 of 22 |
| Abdominal pain | Gastrointestinal disorders | 2 of 43 | 0 of 22 |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | 2 of 43 | 0 of 22 |
| Pyrexia | General disorders | 1 of 43 | 1 of 22 |
| Anemia | Blood and lymphatic system disorders | 0 of 43 | 1 of 22 |
| Streptococcal bacteremia | Infections and infestations | 1 of 43 | 0 of 22 |
| Diverticulitis | Infections and infestations | 1 of 43 | 0 of 22 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Schedule A: SQ 3 Consecutive Days | Schedule B: SQ Once Every 7 Days |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 27 of 43 | 15 of 22 |
| Anemia | Blood and lymphatic system disorders | 24 of 43 | 9 of 22 |
| Thrombocytopenia | Blood and lymphatic system disorders | 18 of 43 | 12 of 22 |
| Leukopenia | Blood and lymphatic system disorders | 18 of 43 | 10 of 22 |
| Fatigue | General disorders | 17 of 43 | 10 of 22 |
| Pyrexia | General disorders | 14 of 43 | 6 of 22 |
| Dizziness | Nervous system disorders | 11 of 43 | 6 of 22 |
| Nausea | Gastrointestinal disorders | 12 of 43 | 3 of 22 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 12 of 43 | 3 of 22 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 7 of 43 | 8 of 22 |
Serious events with the highest arm-level rate: pneumonia (9.1%), febrile neutropenia (4.7%), abdominal pain (4.7%), gastrointestinal hemorrhage (4.7%), anemia (4.5%).
The registry lists serious adverse events and other adverse events by schedule group. For Schedule A, three consecutive days, the serious adverse-event count is 18 participants among 43 at risk; for Schedule B, once every seven days, it is 10 among 22 at risk. The other adverse-event count is listed as 43 among 43 at risk for Schedule A and 22 among 22 at risk for Schedule B. These are recorded counts, not a statistical comparison adjusted for differences in follow-up or participant characteristics.
The serious-event terms listed include Pneumonia at 9.1%, Febrile neutropenia at 4.7%, Abdominal pain at 4.7%, Gastrointestinal hemorrhage at 4.7%, Anemia at 4.5%, and Cellulitis at 4.5%. The registry listing does not specify a denominator or provide arm-specific percentages for these terms, so they should not be interpreted as schedule-specific rates.
In general, adverse-event counts describe events or affected participants as defined by the reporting record; they do not establish that the study drug caused the event. The record does not report death counts. These safety figures should be read alongside the study design and reporting limitations, and they do not fill the gap in the unreported primary response results.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, open-label phase 2 study compared two subcutaneous schedules of decitabine in people with low or intermediate-1 risk myelodysplastic syndromes. It also defines an overall improvement outcome based on complete remission, partial remission, marrow complete remission, or hematologic improvement, with a timeframe of up to one year.
What the record does not establish is the observed overall improvement rate in either group. No group-specific response counts or percentages are reported, and there is no reported contrast, confidence interval, or p-value for the primary outcome. Consequently, the available information does not show whether the schedules produced different response rates, how large any difference might have been, or how precisely an effect was estimated.
The absence of a reported comparison is not evidence that the schedules had the same result. Demonstrating similarity or equivalence requires a defined comparison and sufficiently precise estimates, neither of which is available in the registry’s primary-outcome results. Likewise, the study’s randomized design does not supply a result in the absence of outcome data.
The serious and other adverse-event counts provide some descriptive safety information, but they do not indicate causation and are not a direct measure of overall benefit. The registry does not provide the details needed to compare event rates fully, including a stated denominator for the selected serious-event terms, nor does it report death counts.
In general, a trial result is most informative when the endpoint definition, analysis population, observed counts, comparative estimate, and uncertainty are all available. Here, the design and endpoint are described, while the primary comparative outcome and key analysis details are not reported in the registry record. Conclusions should therefore remain limited to what the record documents: the study’s question, its two schedules, its endpoint definition, and the listed adverse-event counts.
13. Why This Trial Matters Statistically
This study illustrates why a trial’s statistical question and its statistical answer are distinct. The randomized design identifies a planned comparison between two schedules, and the overall improvement rate defines the response outcome. But without the observed response counts and comparative estimate, readers cannot determine the direction, magnitude, or precision of the primary result. A well-defined question is not itself evidence for an answer.
It also shows the importance of reporting the analysis population. The endpoint is specified for a modified intent-to-treat population, yet the record does not define or size that population. Reporting only total enrollment does not tell readers how many participants contributed to the outcome estimate. This distinction matters for understanding both the response percentage and its uncertainty.
The composite endpoint raises a further interpretive issue. Combining several response categories can provide a broad summary, but separate component results help explain what that summary represents. Without component counts, it is not possible to see whether the overall measure reflects a range of responses or is concentrated in one category. The registry gives the definitions but not the category-level results.
Finally, the safety listing demonstrates why counts require context. Group-specific serious and other adverse-event counts are available, while selected serious-event term percentages lack a stated denominator or arm attribution. Descriptive safety data can be useful, but readers need definitions, denominators, and analysis details to make meaningful comparisons. These reporting distinctions are central to sound interpretation of clinical trial evidence.
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 is that the registry record does not report numerical results for the primary endpoint. There are no overall improvement counts or percentages by schedule, no between-schedule estimate, and no confidence interval or p-value. As a result, the comparative efficacy question cannot be answered from the posted results.
The analysis population is described as modified intent-to-treat, but the registry does not define it or report its size. It does not state how many participants were assessed, how many had missing outcome data, or how missing assessments were handled. Enrollment of 67 cannot substitute for those missing analysis details.
The study is labeled randomized and open-label, but the randomization procedure, allocation concealment, baseline characteristics, and response-assessment process are not reported. The schedule descriptions do not include dose amounts or fuller regimen details. These omissions constrain assessment of group comparability and how consistently the response endpoint may have been evaluated.
The registry record does not provide the study’s sample-size justification, a detailed statistical analysis plan, a multiplicity approach, or information about interim analyses. It also does not report separate outcomes for the four response categories included in the overall improvement definition. The absence of these details means readers cannot evaluate the planned analysis or the contribution of individual response categories.
Safety reporting is also incomplete for comparative interpretation. The record lists adverse-event counts and selected serious-event terms, but does not state a denominator or arm assignment for the term percentages. Death counts are not reported in the registry record. These limitations apply to interpretation of the available record and do not establish what may have appeared in other study documents.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) — NCT00619099.
- Registry record last updated 2013-10-24; status last verified 2013-09.
- Results first posted 2013-09-18.
- 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
NCT00619099 is a completed randomized, open-label, parallel phase 2 study of two subcutaneous decitabine schedules in adults with low or intermediate-1 risk myelodysplastic syndromes. Enrollment was 67. The registry lists Schedule A as three consecutive days and Schedule B as once every seven days; dose amounts are not reported in the registry record.
The primary endpoint was overall improvement, defined by complete remission, partial remission, marrow complete remission, or hematologic improvement, in a modified intent-to-treat population over up to one year. The registry record does not report numerical primary-outcome results or a statistical comparison. It also does not define the modified intent-to-treat population or describe missing-data handling.
Adverse-event counts are listed by schedule, along with selected serious-event terms and percentages. The record does not provide death counts, and the denominator and arm attribution for the selected term percentages are not stated.