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 Saracatinib in Treating Patients With Prostate Cancer (NCT01267266), a randomized phase 2 study. The primary outcome is Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01267266 |
| Phase | Phase 2 |
| Condition | Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 31 |
| Arms in the primary outcome | 2 |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Patients with prostate cancer, including hormone-resistant, recurrent, and stage IV prostate cancer, were eligible for this phase 2 study. The registry lists enrollment of 31. The reported primary-outcome groups are much smaller: 3.0 participants in the saracatinib group and 5.0 in the placebo group. How those outcome populations relate to the full enrollment is not reported in the registry record.
Intervention
The intervention was oral saracatinib, taken once daily on days 1–28, with courses repeating every 4 weeks in the absence of disease progression or unacceptable toxicity. The registry describes a lead-in phase and a randomized phase, but does not report all details of the transition between them.
Comparator
The comparator was oral placebo, taken once daily on days 1–28, with courses repeating every 4 weeks under the same stated conditions. Patients in the placebo arm could cross over to saracatinib upon progression. The registry identifies the design as randomized, parallel, and unmasked.
Primary question
The primary question was whether the duration of stable disease, measured as time to progression by CT and/or bone scan or clinical progression, differed between the saracatinib and placebo groups. The outcome was followed for up to 6 months. The registry reports median times and a log-rank comparison, but the small outcome groups and censoring make precision and interpretation important.
3. Trial Design
NCT01267266 is a randomized phase 2 study titled “Saracatinib in Treating Patients With Prostate Cancer.” Its official title describes a randomized discontinuation study of AZD0530 as a metastasis inhibitor in castrate-resistant prostate cancer. The registry lists the allocation as randomized, the masking as none, and the model as parallel. The sponsor is the National Cancer Institute (NCI).
The registry records enrollment of 31 and a start date of 2010-12. Primary completion is listed as 2012-09, and the study status is terminated. The reason for termination is not reported in the registry record. The enrollment count describes the overall registered study; the posted primary-outcome groups contain 3.0 participants assigned to saracatinib and 5.0 assigned to placebo. The record does not explain the full relationship between these counts or provide a complete participant flow.
The intervention descriptions specify oral dosing once daily on days 1-28, with courses repeating every 4 weeks in the absence of progression or unacceptable toxicity. The placebo arm could cross over to saracatinib upon progression. The registry also reports adverse-event groups for a saracatinib lead-in phase and for the randomized saracatinib and placebo phases. Further details about the lead-in process, eligibility at randomization, treatment exposure, and reasons participants did not contribute to the primary outcome are not reported in the registry record.
The primary outcome concerns time to progression, measured by CT and/or bone scan or clinical progression, with a timeframe of up to 6 months. The outcome population description notes that two patients in the placebo arm were censored at 12 and 17 weeks, respectively. The registry does not report a detailed statistical analysis plan, allocation procedure, masking procedures beyond “none,” or a rationale for the enrolled sample size.
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.
Enrollment Phase
| Stage | Arm I (Saracatinib) | Arm II (Placebo) |
|---|---|---|
| STARTED | 33 | 0 |
| COMPLETED | 31 | 0 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | Arm I (Saracatinib) | Arm II (Placebo) |
|---|---|---|
| Withdrawal by Subject | 2 | 0 |
Lead-in Phase
| Stage | Arm I (Saracatinib) | Arm II (Placebo) |
|---|---|---|
| STARTED | 31 | 0 |
| COMPLETED | 8 | 0 |
| NOT COMPLETED | 23 | 0 |
Reasons for not completing this period:
| Reason | Arm I (Saracatinib) | Arm II (Placebo) |
|---|---|---|
| Lack of Efficacy | 20 | 0 |
| Adverse Event | 2 | 0 |
| Withdrawal by Subject | 1 | 0 |
Randomized Phase
| Stage | Arm I (Saracatinib) | Arm II (Placebo) |
|---|---|---|
| STARTED | 3 | 5 |
| COMPLETED | 3 | 5 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Two patients in the placebo arm censored at 12 and 17 weeks, respectively.
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: Patients entering lead-in phase.
| Characteristic | Unit | Arm I (Saracatinib) |
|---|---|---|
| Participants analysed | 31 | |
| Age, Continuous | years | 71 (48 to 87) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 31 |
6. Primary Endpoint
The registry lists the primary outcome as Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.), measured over Up to 6 months..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | weeks |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is titled duration of stable disease and is operationalized as time to disease progression by CT and/or bone scan or clinical progression. It is measured in weeks, summarized by the median and full range, and assessed for up to 6 months. In a time-to-event endpoint, the event is the progression defined by the study; the endpoint represents the time from the applicable starting point to that event. The precise time origin is not reported in the registry record.
Time-to-event outcomes are used when both whether an event occurs and when it occurs matter. They can retain information from participants whose event time is not observed during follow-up through censoring, rather than treating those participants as if they had a known event time. As a general statistical explanation, censoring records that the event time was not observed within the available follow-up; it does not establish what would have happened afterward. The registry specifically notes two placebo participants censored at 12 and 17 weeks, respectively, but does not report why they were censored.
The posted medians are 18.0 weeks for saracatinib and 12.0 weeks for placebo. The reported full ranges are 17.0 to 19.0 weeks and 9.0 to 17.0 weeks, respectively. These summaries describe the observed outcome groups. They do not, on their own, quantify uncertainty around the treatment comparison or establish that the groups differ. A confidence interval for the comparison is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary-outcome data report a median time to progression of 18.0 weeks in the saracatinib group and 12.0 weeks in the placebo group. The full ranges are 17.0 to 19.0 weeks and 9.0 to 17.0 weeks, respectively. These are descriptive summaries for groups of 3.0 and 5.0 participants. They should be read as summaries of the observed participants, not as precise estimates of what would occur in a broader population.
The registry reports a log-rank p-value of 0.20 for the comparison. A p-value describes how compatible the observed data are with a specified statistical model and null hypothesis; it is not the probability that either treatment is effective, nor a measure of the size or clinical importance of a difference. A p-value of 0.20 does not establish that the groups are equivalent, and it does not establish that there is no difference. The registry does not report a confidence interval or a hazard ratio for this outcome, so the precision and range of plausible comparative effects cannot be assessed from those measures.
The sample sizes matter to interpretation. Only 3.0 participants appear in the saracatinib primary-outcome group and 5.0 in the placebo group, despite overall enrollment of 31. The record does not explain why the outcome groups are this small. With few observations, individual event times and censoring can have substantial influence on a median or a test result. The full ranges describe the observed spread but are not confidence intervals and do not convey all uncertainty about the group comparison.
The endpoint population description identifies two placebo participants censored at 12 and 17 weeks. Censoring can be accommodated by time-to-event methods when their assumptions are appropriate, but the reasons for censoring and additional follow-up details are not reported in the registry record. These omissions limit assessment of whether censoring could have affected the comparison.
The record names Kaplan-Meier assessment and a Wilcoxon rank-sum comparison in the endpoint description, while the posted analysis lists a log-rank test. The reported p-value is therefore best described as the registry’s log-rank result; the record does not provide enough detail to reconcile the different method descriptions. Overall, the posted outcome is an imprecise comparison in a very small randomized outcome population. It is not a basis for claiming equivalence, a definitive benefit, or a definitive absence of effect.
9. Statistical Methods Explained
What does a time-to-event endpoint represent?
Time-to-event analysis studies the time until a defined event. For this trial, the event is disease progression assessed by CT and/or bone scan or clinical progression. The registry describes the outcome as duration of stable disease and specifies time to progression as its measure. The time origin for this measure is not reported in the registry record, so the exact starting point cannot be described more specifically.
A time-to-event outcome preserves the timing of observed events rather than reducing every participant’s experience to a simple event/no-event status at one fixed time. It can also incorporate censored observations. In general, censoring means that the event time was not observed during the participant’s recorded follow-up; the exact event time is therefore unknown. It does not mean that the participant experienced no event after follow-up ended. The registry identifies two placebo participants censored at 12 and 17 weeks, respectively, but does not state the reasons for censoring.
What does the Kaplan-Meier method do?
The endpoint description says time to progression will be assessed using the Kaplan-Meier method. As a general statistical explanation, the Kaplan-Meier method estimates the probability of remaining event-free over time while accounting for censored observations. The resulting curve represents the observed time-to-event experience under the method’s assumptions. A median time can be read as the time at which the estimated event-free probability reaches its midpoint, when that point can be estimated.
The posted primary outcome gives medians and full ranges rather than confidence intervals for the group medians. A full range describes the lowest and highest observed values in the summarized group; it is not a measure of the uncertainty around a median. A confidence interval, when reported, expresses uncertainty in an estimated quantity under the specified statistical procedure. No confidence interval for the primary comparison is reported in the registry record.
How should the comparison test be understood?
The endpoint description names a Wilcoxon rank-sum test for comparing groups, while the reported analysis lists a log-rank test and gives p = 0.20. These are the two method descriptions in the record; it does not explain their relationship or identify a separate result for the Wilcoxon rank-sum test. The posted p-value should therefore be attributed to the listed log-rank analysis rather than treated as a result from both tests.
As a general statistical explanation, the log-rank test compares event-time experience across groups while taking account of the timing of events and censoring. Its p-value does not measure the size of the difference. It also does not, by itself, tell readers whether an estimated effect is precise or whether a treatment difference is clinically important. For that, effect estimates and uncertainty intervals are useful, but no hazard ratio or confidence interval for the primary comparison is reported in the registry record.
What do the posted summaries show?
The median time to progression is 18.0 weeks in the saracatinib group and 12.0 weeks in the placebo group. The full ranges are 17.0 to 19.0 weeks and 9.0 to 17.0 weeks. These summaries refer to the reported groups of 3.0 and 5.0 participants. They provide a description of the observed data, but the very small groups mean that the summaries should not be mistaken for stable estimates of the outcome in a larger population.
The p-value of 0.20 is the registry’s reported test result. A p-value is calculated under a null hypothesis and model assumptions; it describes the compatibility of the data with that framework. It is not a posterior probability that the null hypothesis is true, and a result that does not cross a chosen significance threshold does not prove equivalence. The record does not state a threshold for the primary analysis, so no threshold-based conclusion should be inferred from the result alone.
What do planning illustrations mean?
General sample-size planning uses assumptions about a target effect, variability or event pattern, significance level, allocation, and desired power to illustrate how much information might be needed. The planning assumptions associated with this study describe a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. For time-to-event planning, the stated convention is to express the total number of events; other planning quantities are expressed as participants per arm.
Such planning illustrations are hypothetical and are not evidence that the trial was designed or conducted with those assumptions. The registry does not report a sample-size justification or the study’s own planned power calculation. These illustrations must not be read as observed power or as a retrospective measure of whether the trial “had enough power.” The record’s small outcome groups and missing design rationale remain relevant regardless of any hypothetical planning scenarios.
What does the record leave unresolved?
The registry does not provide the individual event times, a full participant flow, the primary analysis population definition, the time origin, reasons for censoring, or a confidence interval and hazard ratio for the primary comparison. It also does not report whether a multiplicity adjustment was planned or used. Without those details, the posted summary can be described, but a fuller independent reconstruction of the trial’s time-to-event analysis is not possible from the registry record.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Log Rank | not reported | 0.200 |
The registry’s reported comparative result is a log-rank p-value of 0.20. The method description for the endpoint also mentions Kaplan-Meier assessment and a Wilcoxon rank-sum test, but no separate result for that test is posted. No hazard ratio or confidence interval for the primary comparison is reported in the registry record.
An independent unadjusted recalculation is not available for this median-time endpoint because the posted summary values are missing or not estimable for a two-arm comparison. The descriptive medians and ranges do not supply enough information to reproduce a time-to-event comparison. There is therefore no recalculated comparative estimate to set against the sponsor’s reported test result. The registry does not indicate a discrepancy between a recalculation and the sponsor analysis.
The sponsor’s p-value should be read as the posted inferential result, not as proof of equivalence or proof that a treatment difference exists. The small outcome groups, stated censoring, absent confidence interval, and incomplete analysis details constrain how much can be concluded from it. No independent recalculation adds precision beyond the registry’s result.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists three secondary outcome entries: toxicity and incidence of adverse events, a second toxicity and incidence of adverse events entry, and correlation of molecular profile with clinical outcomes. The toxicity entry appears twice with slightly different punctuation. The record lists 4 outcome measures and 1 analysis, but does not explain how the outcome entries correspond to those counts or identify which results were analyzed.
When a study evaluates multiple outcomes or makes multiple comparisons, the chance of obtaining at least one apparently unusual result can increase. As a general statistical principle, a prespecified multiplicity strategy can help control that issue. The registry does not report whether the primary or secondary analyses were adjusted for multiplicity, which outcomes were designated in advance, or how any adjustment would have been performed. No conclusion about adjustment should be inferred from the posted p-value alone.
The endpoint population description notes two placebo participants censored at 12 and 17 weeks. Their reasons for censoring are not reported in the registry record. The record also does not report additional missing outcome data, an imputation strategy, or sensitivity analyses addressing missingness. Absence of a description does not establish that no other missing data occurred; it means the registry does not give enough information to assess the issue.
The primary analysis population is not defined in the registry record. The overall enrollment is 31, while the posted primary-outcome groups contain 3.0 and 5.0 participants. The record does not provide a complete flow from enrollment through the lead-in and randomized phases, or explain which participants were included or excluded from the primary analysis. It is therefore not possible to determine from the posted information whether the analysis followed an intention-to-treat principle or another population definition.
Placebo participants could cross over to saracatinib upon progression. The endpoint itself is defined by progression, but the record does not describe how crossover was handled for outcomes measured after progression. It also does not provide a full account of exposure or follow-up after crossover. These details would matter for interpreting later outcomes, but the registry record does not report them.
12. 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 |
|---|---|---|---|
| Saracatinib, Lead-in Phase | 1 | 31 | 3.2% |
| Saracatinib, Randomized Phase | 0 | 3 | 0.0% |
| Placebo, Randomized Phase | 1 | 5 | 20.0% |
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 |
|---|---|
| Saracatinib, Lead-in Phase | 29 of 31 |
| Saracatinib, Randomized Phase | 3 of 3 |
| Placebo, Randomized Phase | 3 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Saracatinib, Lead-in Phase | Saracatinib, Randomized Phase | Placebo, Randomized Phase |
|---|---|---|---|---|
| Anemia | Metabolism and nutrition disorders | 1 of 31 | 0 of 3 | 0 of 5 |
| Muscle weakness | Musculoskeletal and connective tissue disorders | 0 of 31 | 0 of 3 | 1 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Saracatinib, Lead-in Phase | Saracatinib, Randomized Phase | Placebo, Randomized Phase |
|---|---|---|---|---|
| Fatigue | General disorders | 12 of 31 | 2 of 3 | 1 of 5 |
| Anorexia | Metabolism and nutrition disorders | 13 of 31 | 1 of 3 | 1 of 5 |
| Nausea | Gastrointestinal disorders | 9 of 31 | 1 of 3 | 1 of 5 |
| Vomiting | Gastrointestinal disorders | 9 of 31 | 1 of 3 | 1 of 5 |
| Constipation | Gastrointestinal disorders | 8 of 31 | 0 of 3 | 1 of 5 |
| Pain | General disorders | 7 of 31 | 1 of 3 | 1 of 5 |
| Anemia | Blood and lymphatic system disorders | 8 of 31 | 0 of 3 | 0 of 5 |
| Aspartate aminotransferase increased | Investigations | 7 of 31 | 0 of 3 | 0 of 5 |
| Diarrhea | Gastrointestinal disorders | 5 of 31 | 0 of 3 | 1 of 5 |
| Fever | General disorders | 5 of 31 | 0 of 3 | 0 of 5 |
Serious events with the highest arm-level rate: muscle weakness (20.0%), anemia (3.2%).
The adverse-event record separates a saracatinib lead-in phase from randomized saracatinib and placebo phases. In the lead-in group, 1 participant among 31 at risk is recorded with a serious adverse event, and 29 among 31 are recorded with other adverse events. In the randomized saracatinib group, 0 of 3 participants are recorded with a serious adverse event and 3 of 3 with other adverse events. In the randomized placebo group, 1 of 5 is recorded with a serious adverse event and 3 of 5 with other adverse events.
These are counts within the registry’s stated groups, not a randomized comparison adjusted for follow-up, exposure, or participant characteristics. The group sizes differ, and the lead-in group is distinct from the randomized-phase groups. A count of zero in a group of 3 does not demonstrate that an event could not occur, while an event recorded in a small group does not by itself establish a treatment-related difference. The registry does not report deaths in these safety groups.
The listed top serious adverse-event terms are muscle weakness at 20.0% and anemia at 3.2%. The record does not give enough detail alongside these figures to establish their denominator, timing, attribution, or relationship to treatment. Serious adverse events and other adverse events are distinct categories in the registry; the counts should not be combined or interpreted as a complete safety profile. Further details about event severity, duration, management, and causal assessment are not reported in the registry record.
13. What the Result Does, and Does Not, Mean
The posted results describe a small randomized comparison of time to progression. Median time to progression was 18.0 weeks in the saracatinib group and 12.0 weeks in the placebo group, with full ranges of 17.0 to 19.0 weeks and 9.0 to 17.0 weeks. The registry reports a log-rank p-value of 0.20. These registry entries describe the observed data and the posted test; they do not determine the size or precision of a treatment effect.
The result does not establish that the groups are equivalent, nor does it establish that they differ. A p-value is not an estimate of treatment benefit, and no confidence interval or hazard ratio for the comparison is reported. The small primary-outcome groups—3.0 and 5.0 participants—mean that the observed summaries may be sensitive to individual observations. The recorded censoring of two placebo participants is relevant, but the reasons for censoring and other details needed to assess its impact are not reported in the registry record.
The trial status is terminated, but the reason for termination is not reported in the registry record. The record also does not give a complete account of participant flow from enrollment of 31 to the primary-outcome groups. It therefore does not support an explanation for why these group sizes differ from overall enrollment or a judgment about the representativeness of the outcome population.
Safety counts are also descriptive. They are reported separately for the saracatinib lead-in, randomized saracatinib, and randomized placebo groups, with markedly different group sizes. They do not, by themselves, support a comparative safety conclusion. Event attribution and additional safety details are not reported.
In short, the registry records a median-time comparison and a log-rank result but leaves important uncertainty about the analysis populations, precision, censoring, and trial conduct. The posted result should be understood as limited evidence from the recorded participants, rather than as a definitive statement about treatment effects in a broader population.
14. Why This Trial Matters Statistically
This study illustrates why a trial’s overall enrollment and its endpoint analysis population must be distinguished. The registry records enrollment of 31, yet the primary outcome is reported for groups of 3.0 and 5.0 participants. Without a participant flow or explanation of the analysis population, readers cannot tell how the observed endpoint groups arose. That gap affects interpretation before any statistical test is considered.
It also illustrates the difference between descriptive summaries and comparative inference. The medians and full ranges describe observed times, while the log-rank p-value is a test result. Neither the medians nor the p-value supplies the missing information about precision that a confidence interval could convey. In a small time-to-event analysis, censoring and individual event times can be especially important, yet only the censoring of two placebo participants is specifically described.
The registry includes two descriptions of the comparison method: the endpoint text names a Wilcoxon rank-sum test, while the posted analysis identifies a log-rank test. Those methods should not be silently treated as interchangeable. Naming the exact method attached to the posted p-value preserves the distinction and makes the registry’s limited reporting visible.
Finally, the study is a reminder that an unreported analysis plan is not evidence that no plan existed, and a planning illustration is not evidence of the trial’s original design. The record does not report a sample-size justification, multiplicity strategy, detailed analysis population, or reason for termination. Keeping those absences separate from the observed endpoint values is essential to a careful statistical reading.
15. 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 groups are small relative to the registry’s overall enrollment of 31, and the registry does not explain the difference. It does not report a full participant flow, the number screened or eligible, reasons for non-inclusion in the outcome analysis, or the analysis population definition. These omissions limit assessment of selection and completeness.
The outcome is time to progression by CT and/or bone scan or clinical progression, but the precise time origin and assessment schedule are not reported in the registry record. Two placebo participants are identified as censored at 12 and 17 weeks, respectively; the reasons for censoring and any further censoring details are absent. No confidence interval or hazard ratio is posted for the primary comparison, and individual event times are not available in the registry record.
The endpoint description refers to Kaplan-Meier assessment and a Wilcoxon rank-sum test, whereas the analysis entry reports a log-rank test. The record does not clarify whether these references describe different planned and performed methods, or otherwise explain the distinction. This limits evaluation of the analysis as conducted.
The randomized design is described as parallel and unmasked, and placebo participants could cross over upon progression. The record does not report details of allocation, post-progression follow-up, crossover exposure, or any effect of crossover on later outcomes. The reason for termination, sample-size justification, interim analyses, multiplicity strategy, and detailed statistical plan are also not reported in the registry record.
Safety information is presented in separate groups with differing sizes, including a lead-in group. The listed serious-event terms do not include enough contextual detail to assess timing, attribution, or denominators. These limitations do not invalidate the posted summaries; they define what can and cannot be concluded from the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Saracatinib in Treating Patients With Prostate Cancer — NCT01267266.
- Registry record last updated 2015-04-01; status last verified 2013-01.
- Results first posted 2015-04-01.
- 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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19. Record Summary
NCT01267266 is a randomized, unmasked, parallel phase 2 study of saracatinib in prostate cancer, sponsored by the National Cancer Institute (NCI). The registry lists enrollment of 31, a start date of 2010-12, primary completion in 2012-09, and terminated status.
The primary outcome is duration of stable disease, measured as time to progression by CT and/or bone scan or clinical progression for up to 6 months. Median times were 18.0 weeks for saracatinib and 12.0 weeks for placebo; the reported log-rank p-value is 0.20. The outcome groups contained 3.0 and 5.0 participants, and two placebo participants were censored at 12 and 17 weeks, respectively.
The registry does not report a confidence interval or hazard ratio for the comparison, a complete participant flow, or the reason for termination. Its small outcome groups and incomplete analysis details limit interpretation of the posted comparison.