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 Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (NCT03092674), a randomized phase 2, phase 3 study. The primary outcome is Overall Survival (OS) (Phase II).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03092674 |
| Phase | Phase 2, Phase 3 |
| Condition | Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome/Acute Myeloid Leukemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 76 |
| Arms in the primary outcome | 3 |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerns patients age 60 or older with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. The Phase II overall-survival analysis included 76 eligible and evaluable participants: 26 in the azacitidine arm, 25 in the azacitidine plus nivolumab arm, and 25 in the azacitidine plus midostaurin arm. The registry record does not give further baseline characteristics in the posted outcome information, so the similarity of the groups before treatment cannot be assessed from these results alone.
Intervention
The Phase II outcome compares azacitidine alone with azacitidine plus nivolumab and azacitidine plus midostaurin. The registry describes azacitidine as given by injection on a repeated schedule, nivolumab as an intravenous addition, and midostaurin as an oral addition. These are descriptions of the planned treatment arms, not evidence that any regimen had a particular effect.
Comparator
Azacitidine alone is the control arm for the reported Phase II survival outcome. The trial is randomized, with a parallel design and no masking. The registry record lists other treatment approaches in the overall trial title, including decitabine with cytarabine, but the reported Phase II primary analysis population comprises the three azacitidine arms.
Primary question
The reported primary endpoint asks how long participants live after randomization, with death from any cause counted as the event and last contact used for censoring when a participant was not known to have died. The posted results give a median and 95% confidence interval for each arm. They do not report a hazard ratio or a formal between-arm statistical test. Therefore, these medians describe survival within each group but do not, by themselves, establish whether outcomes differ between treatment arms.
3. Trial Design
This was a randomized Phase II/III trial with a parallel-group design and no masking. The registry lists total enrollment as 76 and identifies the National Cancer Institute as sponsor. The record lists the study status as completed, with a start date of 2018-02-02 and primary completion date of 2023-08-01. Those dates describe the registry record; they do not supply additional information about follow-up duration for individual participants.
The overall trial title describes treatment approaches involving azacitidine alone or with nivolumab or midostaurin, as well as decitabine and cytarabine. The primary outcome posted for this analysis is specifically labeled Overall Survival (OS) (Phase II). Its population consists of 76 eligible and evaluable participants allocated among azacitidine, azacitidine plus nivolumab, and azacitidine plus midostaurin. The registry does not include the decitabine and cytarabine arm in that stated primary analysis population.
The arm descriptions specify repeated treatment courses and include routes and schedules for the study drugs. The posted description for the decitabine and cytarabine arm includes induction and begins a maintenance description, but the maintenance text is incomplete in the registry record. Detailed eligibility criteria, randomization procedures, allocation concealment, and the complete protocol are not reported in the registry record. The statistical plan, including any planned comparisons or analysis hierarchy, is also not reported in the registry record.
Randomization can support a fair comparison when the assigned groups are analyzed appropriately, but it does not make descriptive summaries equivalent to a direct treatment comparison. The posted primary outcome gives an estimate for each arm, not a comparative effect estimate. The record therefore supports describing the survival estimates and their uncertainty, while leaving the comparative question unresolved by the posted statistics.
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: 78 participants were initially randomized to the study, 26 per arm. Two were ineligible, one on the Azacitidine+Nivolumab arm and one in the Azacitidine+Midostaurin arm. 76 participants were eligible and included in the primary analysis (26 in the Azacitidine arm, 25 in the Azacitidine+Nivolumab arm, and 25 in the Azacitidine+Midostaurin arm).
Overall Study
| Stage | Azacitidine | Azacitidine + Nivolumab | Azacitidine + Midostaurin |
|---|---|---|---|
| STARTED | 26 | 25 | 25 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 26 | 25 | 25 |
Reasons for not completing this period:
| Reason | Azacitidine | Azacitidine + Nivolumab | Azacitidine + Midostaurin |
|---|---|---|---|
| Adverse Event or Side Effects | 1 | 4 | 4 |
| Refusal Unrelated to Adverse Event | 5 | 1 | 3 |
| Progression/Relapse | 5 | 4 | 8 |
| Death | 4 | 8 | 2 |
| Other - Not Protocol Specified | 11 | 8 | 8 |
Analysis population for the primary outcome, as defined in the registry: The analysis population includes the 76 participants who were eligible and evaluable (26 in the Azacitidine arm, 25 in the Azacitidine+Nivolumab arm, and 25 in the Azacitidine+Midostaurin arm).
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 | Azacitidine | Azacitidine + Nivolumab | Azacitidine +Midostaurin | Total |
|---|---|---|---|---|---|
| Participants analysed | 26 | 25 | 25 | 76 | |
| Age, Continuous | years | 75.5 (61.9 to 86.3) | 76.4 (66.4 to 86.5) | 76.2 (65.7 to 85.8) | 75.6 (61.9 to 86.5) |
| Sex: Female, Male: Female | Participants | 11 | 8 | 9 | 28 |
| Sex: Female, Male: Male | Participants | 15 | 17 | 16 | 48 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 1 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 25 | 23 | 23 | 71 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 1 | 3 |
| Race/Ethnicity, Customized: Race – White | Participants | 23 | 21 | 21 | 65 |
| Race/Ethnicity, Customized: Race – Black | Participants | 2 | 3 | 2 | 7 |
| Race/Ethnicity, Customized: Race – Asian | Participants | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized: Race – Unknown | Participants | 0 | 1 | 2 | 3 |
| Baseline Blast Percentage: <20% (MDS-EB-2) | Participants | 8 | 5 | 6 | 19 |
| Baseline Blast Percentage: >=20% (AML) | Participants | 18 | 20 | 19 | 57 |
| FLT3-Centrally Reviewed: Wild Type FLT3-ITD | Participants | 25 | 21 | 22 | 68 |
| FLT3-Centrally Reviewed: Mutated FLT3-ITD | Participants | 1 | 4 | 3 | 8 |
| Zubrod Performance Status: 0-1 | Participants | 21 | 21 | 20 | 62 |
| Zubrod Performance Status: 2-4 | Participants | 5 | 4 | 5 | 14 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival (OS) (Phase II), measured over Day of registration on study until death from any cause, assessed for up to 5 years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Overall survival measures time from randomization until death from any cause. In this trial, observations for participants not known to have died were censored on the day of last contact. The endpoint timeframe is listed as from the day of registration on study until death from any cause, assessed for up to 5 years; the endpoint description also defines the time origin as randomization. The registry uses the median as its summary measure and reports a 95% confidence interval for each treatment arm.
In general, a time-to-event endpoint can incorporate both the timing of events and follow-up that ends before an event is observed. Censoring records that an event had not been observed by the last known contact; it does not establish what happened after that point. The median survival is the time by which the estimated survival experience reaches the halfway point. It is useful as an interpretable summary of a survival distribution, but it does not describe every participant’s outcome or the shape of the whole distribution.
The confidence interval conveys uncertainty around the estimated median. A broad interval indicates that the median is not estimated precisely. It is not a range containing a fixed fraction of individual survival times, and overlap or non-overlap alone is not a substitute for a formal comparison between arms.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports median overall survival of 6.2 months for azacitidine, with a 95% confidence interval from 3.9 to 10.0 months. For azacitidine plus nivolumab, the median is 5.2 months, with a 95% confidence interval from 1.1 to 13.1 months. For azacitidine plus midostaurin, the median is 7.4 months, with a 95% confidence interval from 2.9 to 16.4 months. These are arm-specific estimates for the eligible and evaluable Phase II population.
The intervals are wide, particularly for the two combination arms, so the estimates are imprecise. The uncertainty means the reported medians should not be read as exact or stable descriptions of the survival experience that would necessarily recur in another study. A confidence interval expresses uncertainty about an estimated quantity under the assumptions of the analysis; it does not state that all individual survival times lie within its limits.
The registry record reports no hazard ratio or formal statistical test comparing these arms. The observed medians alone do not quantify a randomized treatment contrast, account for the timing of all observed events in a comparative model, or establish that any arm differs from another. In general, survival comparisons often use methods that incorporate the full event and censoring information, but the specific comparative method and result are not reported in the registry record. The medians should therefore be read descriptively, not as proof of a treatment advantage or disadvantage.
The analysis population is stated to include all 76 participants who were eligible and evaluable: 26 assigned to azacitidine, 25 to azacitidine plus nivolumab, and 25 to azacitidine plus midostaurin. The record does not say whether this population is identical to all randomized participants, nor does it explain how eligibility or evaluability was determined. That limits assessment of the analysis population and of whether exclusions after randomization could affect interpretation.
The endpoint description says that participants not known to have died were censored at last contact. The amount and pattern of censoring, follow-up completeness, and the number of participants at risk over time are not reported in the registry record. These details matter because survival estimates depend on follow-up and on how censoring relates to participants’ outcomes. The posted results provide a useful description of the recorded Phase II medians, but not enough comparative or follow-up detail to support a stronger conclusion.
9. Statistical Methods Explained
What does a median survival estimate describe?
Overall survival is a time-to-event outcome: the event is death from any cause, and the time origin is described as randomization. The registry reports median survival separately by treatment arm. In general, the median is the point at which the estimated survival function reaches one half. It is a summary of the group’s survival distribution, rather than an average or a statement about each participant. It also does not indicate how survival differs between groups unless a comparative analysis is reported.
Time-to-event methods are designed for situations in which participants have different lengths of observation. A participant who has not died by the last known contact contributes follow-up until that contact and is then censored, as stated in the outcome description. Censoring does not mean that the participant experienced the event at that time, and it does not mean that the participant remained event-free afterward. In general, valid interpretation depends on appropriate handling of censoring and adequate follow-up. The registry record does not report censoring counts or patterns.
How should the confidence intervals be read?
The registry gives a 95% confidence interval for each median: 3.9 to 10.0 months for azacitidine, 1.1 to 13.1 months for azacitidine plus nivolumab, and 2.9 to 16.4 months for azacitidine plus midostaurin. In general, a confidence interval describes the uncertainty associated with an estimate under the statistical method and assumptions used. It is not a prediction interval for individuals and does not imply that a fixed share of participants’ survival times falls inside its endpoints.
The reported intervals are broad, indicating substantial uncertainty around the arm-specific medians. Confidence intervals for separate arms are not themselves a direct test of the difference between arms. Even when intervals overlap, a comparison requires a suitable estimate and test for the contrast of interest; the registry does not report those for this endpoint.
What information is needed for a treatment comparison?
A direct comparative analysis would need to estimate the contrast between assigned arms and communicate its uncertainty. For survival data, a hazard ratio is one possible comparative measure, while other approaches can compare survival distributions or survival probabilities at specified times. In general, the choice depends on the scientific question and on the assumptions that are appropriate for the data. The registry record reports no hazard ratio, no comparative confidence interval, and no p-value for the Phase II overall-survival outcome. The statistical plan and the method used to calculate the posted medians and intervals are not reported in the registry record.
The registry lists a randomized design, which is relevant because random assignment is intended to make groups comparable on average at the outset. However, interpreting results still depends on the analysis population, adherence to assigned treatment, follow-up, and any exclusions. The primary analysis population is described as eligible and evaluable participants. Whether the analysis followed an intention-to-treat principle, and how any participants were handled if they did not meet those criteria, are not reported in the registry record.
What does the sample-size context mean?
In general, a sample-size calculation is a planning exercise based on assumptions about the outcome, target effect, significance level, allocation, and statistical method. It does not show that a study had a particular probability of detecting its observed result after the fact. The registry record does not report the trial’s own sample-size justification or the assumptions used to plan enrollment. Any planning illustration associated with the posted results should be understood as an illustration based on the observed effect and stated assumptions, not as the trial’s original design calculation or observed power.
For time-to-event outcomes, event counts and follow-up can influence the information available for estimating a treatment contrast. The registry record gives no comparative event count or sponsor-reported hazard ratio for this primary outcome. It is therefore not possible to assess the precision of a direct treatment contrast from the posted median estimates alone.
Why are more detailed statistical methods important?
General statistical interpretation of a randomized survival study considers the endpoint definition, time origin, censoring, analysis population, and comparative estimand together. It also considers whether the analysis accounts for multiple comparisons and whether any planned interim analyses affected interpretation. None of the trial’s detailed statistical plan, interim-analysis procedures, multiplicity adjustments, or model diagnostics are reported in the registry record. These omissions do not invalidate the descriptive medians, but they restrict how fully their derivation and comparative meaning can be evaluated.
10. Multiplicity, Missing Data and Analysis Populations
The trial includes several treatment approaches in its overall title, and the reported Phase II primary outcome covers three azacitidine-based arms. Multiple arms can create multiple possible comparisons and outcomes. In general, testing many hypotheses without an appropriate plan can increase the chance of a misleading positive finding. The registry record does not report a hierarchy of comparisons, a multiplicity adjustment, or the statistical plan for handling multiple outcomes. It also does not report interim analyses or stopping rules.
The primary analysis population is described as 76 eligible and evaluable participants: 26 in the azacitidine arm, 25 in the azacitidine plus nivolumab arm, and 25 in the azacitidine plus midostaurin arm. The registry record does not explain the criteria for being eligible and evaluable, whether any randomized participants were excluded, or whether the analysis used an intention-to-treat population. The distinction matters because excluding participants after randomization can affect the comparability created by random assignment.
For survival, the endpoint description states that participants not known to have died were censored at their last contact. The registry record does not report the extent of censoring, reasons for loss of follow-up, missing baseline information, or sensitivity analyses for missing outcome information. In general, censoring is informative only up to the last known follow-up, and interpretation relies on assumptions about participants whose outcomes are not observed afterward. The posted record is not detailed enough to evaluate those assumptions.
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 |
|---|---|---|---|
| Azacitidine | 9 | 25 | 36.0% |
| Azacitidine + Nivolumab | 20 | 25 | 80.0% |
| Azacitidine +Midostaurin | 17 | 23 | 73.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Azacitidine | 24 of 26 |
| Azacitidine + Nivolumab | 25 of 25 |
| Azacitidine +Midostaurin | 23 of 25 |
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 |
|---|---|
| Azacitidine | 23 of 25 |
| Azacitidine + Nivolumab | 23 of 25 |
| Azacitidine +Midostaurin | 22 of 23 |
Most frequent serious adverse event terms
| Event term | Organ system | Azacitidine | Azacitidine + Nivolumab | Azacitidine +Midostaurin |
|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 4 of 25 | 8 of 25 | 6 of 23 |
| Sepsis | Infections and infestations | 2 of 25 | 7 of 25 | 2 of 23 |
| Lung infection | Infections and infestations | 0 of 25 | 5 of 25 | 5 of 23 |
| Anemia | Blood and lymphatic system disorders | 2 of 25 | 5 of 25 | 2 of 23 |
| Platelet count decreased | Investigations | 1 of 25 | 5 of 25 | 2 of 23 |
| White blood cell decreased | Investigations | 0 of 25 | 4 of 25 | 3 of 23 |
| Hypotension | Vascular disorders | 1 of 25 | 4 of 25 | 2 of 23 |
| Neutrophil count decreased | Investigations | 0 of 25 | 3 of 25 | 3 of 23 |
| Heart failure | Cardiac disorders | 0 of 25 | 1 of 25 | 4 of 23 |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | 1 of 25 | 2 of 25 | 2 of 23 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Azacitidine | Azacitidine + Nivolumab | Azacitidine +Midostaurin |
|---|---|---|---|---|
| White blood cell decreased | Investigations | 18 of 25 | 13 of 25 | 15 of 23 |
| Anemia | Blood and lymphatic system disorders | 13 of 25 | 12 of 25 | 13 of 23 |
| Constipation | Gastrointestinal disorders | 13 of 25 | 7 of 25 | 17 of 23 |
| Platelet count decreased | Investigations | 12 of 25 | 11 of 25 | 13 of 23 |
| Fatigue | General disorders | 12 of 25 | 8 of 25 | 15 of 23 |
| Neutrophil count decreased | Investigations | 12 of 25 | 10 of 25 | 13 of 23 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 9 of 25 | 11 of 25 | 13 of 23 |
| Hyponatremia | Metabolism and nutrition disorders | 14 of 25 | 9 of 25 | 10 of 23 |
| Lymphocyte count decreased | Investigations | 9 of 25 | 11 of 25 | 9 of 23 |
| Nausea | Gastrointestinal disorders | 9 of 25 | 6 of 25 | 12 of 23 |
Serious events with the highest arm-level rate: febrile neutropenia (32.0%), sepsis (28.0%), lung infection (21.7%), anemia (20.0%), platelet count decreased (20.0%).
The registry reports serious adverse-event counts among participants at risk: 9 of 25 for azacitidine, 20 of 25 for azacitidine plus nivolumab, and 17 of 23 for azacitidine plus midostaurin. These are counts of participants reported as affected, paired with the corresponding at-risk counts. They should not be treated as comparative estimates of treatment effect: the registry record does not provide a statistical comparison, and the at-risk counts are not the same across all three groups.
In general, adverse-event summaries depend on how events are defined, collected, attributed, and followed. The record lists febrile neutropenia at 32.0%, sepsis at 28.0%, lung infection at 21.7%, anemia at 20.0%, platelet count decreased at 20.0%, and heart failure at 17.4% among the listed serious terms. The registry entries do not make the denominator or arm-specific distribution for these term percentages clear, so they should not be assigned to a particular arm.
Serious adverse-event counts do not by themselves establish causation or permit a full benefit-risk assessment. The registry also lists deaths by group, but the posted outcome information does not provide enough context to interpret those figures as a comparative safety measure.
12. What the Result Does, and Does Not, Mean
The posted Phase II results describe median overall survival in three randomized groups. The registry reports medians of 6.2 months for azacitidine, 5.2 months for azacitidine plus nivolumab, and 7.4 months for azacitidine plus midostaurin, each with a 95% confidence interval. The estimates are uncertain, and the intervals are broad. They describe the observed analysis population rather than guaranteeing similar outcomes for every participant or future group.
The results do not establish that one treatment arm is superior, equivalent, or inferior to another. No comparative hazard ratio, comparative confidence interval, or formal test is reported for this primary outcome. Comparing the numerical medians directly is not a substitute for a prespecified analysis of the difference between groups. Nor does a median summarize the complete time-to-event pattern.
The registry identifies the analysis population as eligible and evaluable participants, but does not report how that population was determined or whether all randomized participants were included. It also does not report detailed follow-up, censoring information, or the full statistical plan. These gaps make it difficult to assess the robustness and generalizability of the estimates from the registry record alone.
In general, randomized trial results are interpreted by considering the study design, the population analyzed, the endpoint, the comparative estimate, and its uncertainty together. Here, the available primary outcome is descriptive by arm. It can be used to understand the reported Phase II survival summaries and their precision, but it cannot answer a definitive comparative question from the posted statistics. The record also includes serious adverse-event counts, which are descriptive and should not be treated as proof that an event was caused by a treatment.
13. Why This Trial Matters Statistically
This trial illustrates why endpoint summaries and comparative inference are not interchangeable. Overall survival is a clinically interpretable time-to-event measure, and reporting medians with confidence intervals gives readers information about both the estimated survival experience in each arm and the uncertainty around those estimates. The intervals in the posted results are broad, making precision an important part of the interpretation rather than a technical footnote.
It also illustrates the limits of reading randomized studies through arm-specific summaries alone. Randomization is part of the design, but a claim about differences between assigned treatments requires a comparative estimate and an appropriate analysis. The registry record reports the three Phase II medians without a hazard ratio or formal comparison. The observed ordering of medians is not by itself evidence that one regimen produces longer survival.
The record further highlights the importance of transparent analysis populations. It describes the 76 participants as eligible and evaluable but does not report whether that group includes every randomized participant or how evaluability was determined. Such information helps readers assess how closely the analysis preserves the randomized comparison.
Finally, multiple arms, outcomes, safety summaries, and potentially planned comparisons make the statistical plan important. The registry does not report multiplicity procedures or detailed analysis methods. A clear account of those choices, along with follow-up and censoring information, would help readers understand the scope and reliability of the findings. The available record supports a careful descriptive reading, while leaving important comparative and methodological questions unanswered.
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 outcome is labeled as a Phase II endpoint, and the posted analysis includes the three azacitidine-based arms. Although the overall trial title also describes decitabine and cytarabine, those treatments are not part of the stated population for this survival result. The registry record does not explain the relationship between this Phase II analysis and any Phase III analyses or outcomes.
The main limitation for interpreting treatment differences is the absence of a comparative survival estimate or test. Only arm-specific medians and confidence intervals are posted. The registry record also does not report the detailed statistical method, analysis plan, multiplicity approach, interim analyses, or planned sample-size justification.
The population is described as eligible and evaluable, but the record does not define those terms or say whether any randomized participants were excluded. Follow-up completeness, censoring counts, and reasons for missing outcome information are not reported. These omissions limit assessment of possible selection and censoring effects.
The serious adverse-event summary gives affected and at-risk counts, but the record does not provide a comparative safety analysis. For the listed serious-event terms, arm-specific counts and the context for the percentages are not clear in the registry entries. The arm description for decitabine and cytarabine also has an incomplete maintenance passage. These gaps restrict interpretation of the full trial record beyond the stated Phase II survival summaries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome — NCT03092674.
- Registry record last updated 2025-01-16; status last verified 2024-12.
- Results first posted 2024-07-23.
- 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
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18. Record Summary
The registry identifies NCT03092674 as a randomized Phase II/III parallel trial with no masking, sponsored by the National Cancer Institute. It lists enrollment as 76, a start date of 2018-02-02, primary completion on 2023-08-01, and completed status. The overall trial concerns older patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome and includes several treatment approaches.
The posted primary result is Phase II overall survival among 76 eligible and evaluable participants in three azacitidine-based arms. The registry reports an arm-specific median and 95% confidence interval for each, but no comparative hazard ratio or formal test. Serious adverse-event counts are also posted. Detailed statistical methods, multiplicity handling, the sample-size justification, and important analysis-population and follow-up details are not reported in the registry record.