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 Abemaciclib in Patients With Oligodendroglioma (NCT03969706), a na phase 2 study. The primary outcome is Progression-free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03969706 |
| Phase | Phase 2 |
| Condition | Oligodendroglioma, Adult |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Stephen Bagley, MD, MSCE |
| Results posted | Yes |
2. Clinical Question
Population
Adults with recurrent oligodendroglioma were the intended population. The condition is recorded as adult oligodendroglioma, and the study title identifies recurrent disease. The registry record does not report further eligibility details or describe the characteristics of enrolled participants.
Intervention
The intervention was abemaciclib 200 MG, administered as a tablet by mouth twice daily on 28-day cycles. The arm description says treatment continued until tumor progression or unacceptable toxicity. The record does not report adherence or treatment exposure for participants.
Comparator
There was no comparison group: this was a single-group, single-arm study with no allocation to alternative treatments. Outcomes in the treated group therefore cannot be directly contrasted with outcomes under another therapy or with a concurrent control group.
Primary question
The primary endpoint concerned progression-free survival six months after initiation of study therapy. It classified participants according to tumor progression, death due to disease or toxicity, or being alive without tumor progression. The registry record does not report the endpoint result or the number meeting either outcome category.
3. Trial Design
This was a Phase II, single-arm, open-label study of abemaciclib in patients with recurrent oligodendroglioma. The registry records an enrollment of 10 and lists one study arm. Allocation is recorded as not applicable, and masking as none. With no control arm and no masking, the design describes outcomes among participants receiving the study treatment rather than a randomized comparison between treatments.
The arm description specifies abemaciclib 200mg tablets taken by mouth twice daily in 28-day cycles, with treatment continuing until tumor progression or unacceptable toxicity. The registry lists safety and tolerability, objective radiographic response, progression-free survival, and overall survival among the secondary outcomes. The primary endpoint is progression-free survival at six months after therapy initiation.
The recorded study start date is 2019-10-15, the primary completion date is 2024-09-15, and the status is completed. These dates describe the registered study timeline; they do not establish when individual participants began or stopped treatment. The registry record does not report participant-level follow-up, treatment duration, eligibility criteria in detail, or the statistical analysis plan. It also does not report a control-group rationale or a sample-size justification.
Because the study has one arm, any outcome count is descriptive of that group. The design cannot isolate a treatment effect from other explanations for an observed outcome in the way a suitable concurrent comparison may help to do. The registry record does not report a primary endpoint analysis, so the design description alone does not establish the frequency of progression-free survival at the specified time.
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 | Single Arm |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
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 | Single Arm |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 50 (44 to 55) |
| Sex/Gender, Customized: Male | participants | 5 |
| Sex/Gender, Customized: Female | participants | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 8 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Brain tumor / study-specific baseline (KPS, prior lines chemo, prior RT): 1 prior line of systemic therapy | participants | 5 |
| Brain tumor / study-specific baseline (KPS, prior lines chemo, prior RT): 2 prior lines of systemic therapy | participants | 0 |
| Brain tumor / study-specific baseline (KPS, prior lines chemo, prior RT): 3 prior lines of systemic therapy | participants | 1 |
| Brain tumor / study-specific baseline (KPS, prior lines chemo, prior RT): 4 or greater prior lines of systemic therapy | participants | 4 |
| Brain tumor / study-specific baseline (KPS, prior lines chemo, prior RT): 1 prior line of alkylating chemotherapy | participants | 6 |
| Brain tumor / study-specific baseline (KPS, prior lines chemo, prior RT): 2 prior lines of alkylating chemotherapy | participants | 4 |
| Brain tumor / study-specific baseline (KPS, prior lines chemo, prior RT): Prior Radiotherapy | participants | 10 |
| Brain tumor / study-specific baseline (KPS, prior lines chemo, prior RT): Karnofsky Performance Status of 90% | participants | 9 |
| Brain tumor / study-specific baseline (KPS, prior lines chemo, prior RT): Karnofsky Performance of 60% | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival, measured over 6 months after initiation of study therapy.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is progression-free survival, assessed six months after initiation of study therapy. The registry describes two outcome categories: tumor progression, as measured by modified RANO criteria, or death due to disease or toxicity; and being alive without tumor progression. The endpoint is recorded in participants, as a count rather than a continuous measurement.
Progression-free survival is used in oncology studies to describe whether participants remain alive without documented progression over a defined follow-up period. It brings progression and death into the endpoint definition, so the result is not simply a measure of tumor shrinkage or radiographic response. The specified assessment time gives the endpoint a common reference point, although the registry record does not describe the assessment schedule or how incomplete follow-up was handled.
The registry record does not report the number of participants in either endpoint category, an estimated proportion, a confidence interval, or a statistical test. Therefore the endpoint definition can be explained, but its observed result and precision cannot be evaluated from the registry record. The listed secondary outcomes include objective radiographic response, progression-free survival, overall survival, and safety and tolerability; their inclusion does not supply results for the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the primary outcome and its assessment time, but does not report a numerical result for progression-free survival. In particular, it does not state how many participants were alive without tumor progression at six months, how many had progression or a qualifying death, or how participants with incomplete status were handled. No estimate of the endpoint’s frequency or uncertainty can therefore be interpreted from this record.
The enrollment is 10, and the study has a single arm. That information describes the scale and structure of the trial, not its efficacy result. With no concurrent comparator, outcomes within the arm cannot by themselves establish what would have happened to comparable participants under another treatment or without the study intervention. Any interpretation should remain descriptive and should not be treated as a causal treatment comparison.
The registry records selected safety counts: in the single arm, 1 participant is listed as affected by a serious adverse event among 10 at risk; other adverse events are listed for 10 among 10 at risk; and 3 deaths are reported. Alanine aminotransferase increased is the listed top serious adverse event term, with 10.0%. These safety figures do not establish that any event was caused by treatment. The record does not give event-level timing, severity details beyond the serious-event classification, attribution, or the relation of deaths to the endpoint.
The record lists 5 outcome measures and 0 analyses. It does not provide a statistical test, model, confidence interval, or analysis population for the primary endpoint. Consequently, there is no reported inferential result to assess for statistical uncertainty or evidence against a null hypothesis. A missing analysis is not evidence that the endpoint was met or not met.
Any planning illustration based on an observed effect should be kept separate from trial findings. Sample-size calculations describe hypothetical designs under stated assumptions; they are not observed power and do not replace the trial’s endpoint result. The registry record does not report the trial’s own sample-size justification. Overall, the available record supports description of the design, endpoint definition, and selected adverse-event counts, but not a conclusion about the primary outcome.
9. Statistical Methods Explained
Statistical methods determine how trial observations are converted into estimates and how uncertainty is described. The registry record identifies a count-based primary endpoint at six months but reports 0 analyses. It does not report the analysis method, an estimated endpoint result, a confidence interval, or a hypothesis test. The endpoint can therefore be defined, but no inferential calculation can be interpreted from the registry record.
What does a participant count represent?
A count records how many participants fall into a specified outcome category. For this endpoint, the categories are progression or death due to disease or toxicity, and alive without tumor progression at the specified assessment time. To interpret such a count fully, readers need the analyzed population, the outcome counts, and an account of participants whose status is unknown. These details are not reported in the registry record. The enrollment figure alone cannot substitute for the number assessed or the number in either endpoint category.
Why does the single-arm design matter?
A single-arm study observes outcomes in one treatment group. It can describe the experience of that group, but it does not directly estimate a difference between treatment strategies. Without a control group, differences that might otherwise be attributed to treatment cannot be separated from other influences on outcome using a randomized comparison. This is a general design limitation, not a claim about what happened to participants in this study.
The study is open-label, with masking recorded as none. In general, knowledge of treatment assignment can affect subjective aspects of care, reporting, or assessment. Radiographic criteria can structure evaluations, but the registry record does not describe who assessed scans, whether assessments were independently reviewed, or whether any other safeguards were used. Those details are not reported in the registry record.
How should a confidence interval be read?
In general, a confidence interval gives a range of values compatible with the data under a specified statistical procedure. It communicates precision as well as an estimate: a wider interval indicates less precision than a narrower one. A confidence interval does not show the probability that a particular treatment effect is true. No confidence interval for the primary endpoint is reported in the registry record, so the precision of the endpoint estimate cannot be assessed.
What can a significance test show?
In general, a significance test evaluates how compatible observed data are with a specified null hypothesis, under the test’s assumptions. A p-value is not the probability that the null hypothesis is true, and a small p-value alone does not establish clinical importance. The registry record does not report a primary endpoint test or p-value. It also does not report the null hypothesis or a prespecified analysis plan, so readers should not infer one.
What do planning calculations mean?
General sample-size calculations estimate the amount of information a hypothetical study might need under particular assumptions. The planning illustration associated with the posted results is described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. For time-to-event calculations, the stated quantity is the total number of events; other calculations are expressed as participants per arm. These assumptions describe a planning illustration, not the design of this single-arm trial. Its outputs are not observed power, and should not be read as the trial’s achieved power or as evidence that the endpoint was met. The registry record does not report the trial’s own sample-size justification.
Over-dispersion is a general issue for count outcomes: observed variability can exceed what a simple model assumes, making standard errors too small if the extra variability is ignored. Whether over-dispersion is relevant depends on the outcome and analysis model. The registry record does not report a count model or a dispersion estimate, so no conclusion can be drawn about its role in this study.
For time-to-event outcomes, methods may account for the timing of events and censoring, when a participant’s event status is unknown after a point in follow-up. The primary endpoint is described as an assessment at six months, but the registry record does not report a time-to-event analysis, censoring rules, or handling of missing status. It is not appropriate to assume that a particular survival estimator or model was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures, including the primary progression-free survival endpoint and secondary outcomes for safety and tolerability, objective radiographic response, progression-free survival, and overall survival. It records 0 analyses. The registry record does not report a multiplicity strategy, such as a hierarchy of tests or adjustment for testing multiple outcomes. Without a reported analysis plan, the implications of examining several outcomes cannot be determined.
The record also does not describe how missing endpoint assessments were handled. For a six-month outcome, incomplete follow-up or an unavailable assessment can affect which participants contribute to an estimate and how uncertainty is represented. The registry record does not report the number with missing status, the analysis population, or any imputation or censoring approach. No missingness pattern or assumption should be inferred.
The outcome description includes progression, death due to disease or toxicity, and being alive without progression. It does not specify how other circumstances were classified, how assessment timing was managed, or how deaths not described in the endpoint definition were treated. These details are not reported in the registry record. Without the analysis population, endpoint counts, and missing-data approach, the six-month result cannot be reconstructed from the enrollment figure.
In general, an analysis population defines which participants are included in an analysis and under what rules. The registry record does not state whether the primary analysis used all enrolled participants, participants who started treatment, or another population. It is therefore not possible to characterize the analysis as intention-to-treat or per-protocol.
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 |
|---|---|---|---|
| Single Arm | 1 | 10 | 10.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Single Arm | 3 of 10 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Single Arm | 10 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | Single Arm |
|---|---|---|
| Alanine aminotransferase increased | Hepatobiliary disorders | 1 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Single Arm |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | 10 of 10 |
| Fatigue | General disorders | 4 of 10 |
| Nausea | Gastrointestinal disorders | 3 of 10 |
| Creatinine increased | Renal and urinary disorders | 3 of 10 |
| Constipation | Gastrointestinal disorders | 2 of 10 |
| Abdominal Pain | Gastrointestinal disorders | 2 of 10 |
| Dysgeusia | Gastrointestinal disorders | 2 of 10 |
| Flatulence | Gastrointestinal disorders | 2 of 10 |
| Alopecia | Skin and subcutaneous tissue disorders | 2 of 10 |
| Insomnia | Psychiatric disorders | 2 of 10 |
Serious events with the highest arm-level rate: alanine aminotransferase increased (10.0%).
The registry reports one single-arm safety group. It lists serious adverse events for 1 participant among 10 at risk, other adverse events for 10 among 10 at risk, and 3 deaths. These figures describe the entries recorded in the registry; the record does not provide a full event listing or explain the observation period for each category.
Alanine aminotransferase increased is listed as the top serious adverse event term, with 10.0%. This percentage is a registry entry for that term, not a rate that can be generalized beyond the recorded group. The record does not state the event’s timing, duration, clinical severity, or whether investigators considered it related to treatment.
Serious adverse events and other adverse events are separate reporting categories. The fact that all participants at risk are listed for other adverse events does not mean that all had a serious event. Nor does the death count establish that deaths were caused by treatment or occurred during treatment. The registry record does not report the relationship between the deaths and adverse events, the endpoint, or treatment exposure. These counts should be read as safety reporting, not as a causal comparison or an overall estimate of risk relative to another treatment.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed, open-label Phase II study evaluated abemaciclib in a single arm for recurrent oligodendroglioma, with six-month progression-free survival as the primary endpoint. It also documents the treatment schedule, enrollment, selected adverse-event figures, and the registered study timeline. These registry entries help readers understand the question and structure of the investigation.
The record does not report the primary endpoint result. It therefore does not show how many participants were alive without progression at six months, how many experienced progression or a qualifying death, or how precise any endpoint estimate might be. The listed enrollment cannot be used to fill in those missing outcome data. The record also lists secondary outcomes without reporting their results.
Even if an outcome estimate were available, the single-arm design would describe outcomes in the treated group rather than provide a randomized comparison. A comparison with a different treatment, usual care, or no treatment is not included in the registered design. This limits what can be concluded about whether observed outcomes were caused by the intervention.
The safety entries document reported counts and a listed serious adverse event term, but do not establish treatment attribution. Event timing and detailed assessment information are not reported in the registry record. Safety counts from a single group also do not provide a direct comparative estimate of harms.
Thus, the registry record supports a description of the study design and certain recorded safety data, but it does not support a conclusion about the primary efficacy outcome, treatment benefit, or comparative safety. A planning illustration, if considered, concerns assumptions for a hypothetical study and is not a substitute for observed trial results or a measure of achieved power.
13. Why This Trial Matters Statistically
This study illustrates why a clearly defined endpoint and a reported analysis are both needed for statistical interpretation. The registry defines progression-free survival at six months and specifies which clinical events count toward it. That definition clarifies the intended measurement, but without the observed categories or an analysis, readers cannot evaluate the outcome’s frequency or precision.
The single-arm design also makes the distinction between description and comparison especially important. A study can record what happens in its treatment group, but a treatment effect is inherently comparative. The record contains no concurrent control arm, so the design does not provide a randomized estimate of how outcomes differ under another strategy.
Reporting safety counts alongside a treatment description is useful, but counts require context. Serious-event classification, other adverse-event reporting, deaths, attribution, and time at risk answer different questions. The registry offers selected counts but not the detailed event context needed to assess timing or causal relationship. Keeping those interpretations separate avoids reading a safety listing as a comparative risk estimate.
Finally, planning assumptions and trial findings serve different purposes. A planning calculation can illustrate how design choices affect the information a future study may need, while observed results describe what occurred in a completed study. Neither should be mistaken for the other. This record underscores the importance of reporting endpoint results, uncertainty, analysis populations, and missing-data methods so that readers can distinguish what the design intended to measure from what the data demonstrate.
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 main trial-specific limitation is the absence of a reported primary endpoint result. Although progression-free survival is defined at six months, the registry record does not report outcome counts, an estimate, or an interval describing precision. The record also does not report the analyses for the listed secondary outcomes.
The single-arm design has no concurrent control group. As a result, it cannot directly compare outcomes with another treatment strategy. The open-label design and absence of masking are recorded, but the registry record does not describe who assessed radiographic progression or whether independent review was used. Such details are not reported in the registry record.
The enrollment is 10, but the record does not report the number included in each outcome analysis, participant-level follow-up, or completeness of six-month assessment. It does not describe handling of missing data, protocol deviations, treatment discontinuation, or censoring. The arm description states that treatment continued until progression or unacceptable toxicity, but actual exposure and reasons for stopping are not reported.
The registry lists safety counts, including deaths and selected adverse-event information, but does not report detailed event timing, duration, attribution, or a full account of events. The relationship between the reported deaths and treatment or the primary endpoint is not reported in the registry record. In addition, the record does not report the statistical analysis plan, multiplicity handling, or the trial’s sample-size justification. These gaps limit assessment of both outcome interpretation and the completeness of reporting.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Abemaciclib in Patients With Oligodendroglioma — NCT03969706.
- Registry record last updated 2026-09-25; status last verified 2026-06.
- Results first posted 2026-09-25.
- 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
NCT03969706 is a completed Phase II, single-arm, open-label study of abemaciclib in patients with recurrent oligodendroglioma. The registry records enrollment of 10, a start date of 2019-10-15, and primary completion on 2024-09-15. The intervention is abemaciclib 200 MG by mouth twice daily on 28-day cycles, with treatment continuing until progression or unacceptable toxicity.
The primary endpoint is progression-free survival six months after therapy initiation, defined by progression or death due to disease or toxicity versus being alive without progression. The registry lists 5 outcome measures and 0 analyses, and does not report a primary endpoint result. Safety entries include 1 serious adverse event among 10 at risk, other adverse events for 10 among 10 at risk, 3 deaths, and alanine aminotransferase increased at 10.0% as the top serious adverse event term. The single-arm design does not provide a randomized comparison.