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 Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma (NCT00432458), a randomized phase 3 study. The primary outcome is Time to Disease Progression (TTP).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00432458 |
| Phase | Phase 3 |
| Condition | Multiple Myeloma and Plasma Cell Neoplasm |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 68 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Mayo Clinic |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled patients with early stage multiple myeloma, also identified in the registry under multiple myeloma and plasma cell neoplasm. The primary analysis included all randomized participants on an intent-to-treat basis. The registry record does not provide further eligibility detail in the results presented, so characteristics such as disease burden or prior treatment cannot be described from this record.
Intervention
One group received thalidomide with zoledronic acid. The registry labels this Arm I: Thal/ZLD. The rationale recorded for the study describes zoledronate as intended to prevent bone loss and stop cancer-cell growth in bone, and thalidomide as intended to block blood flow to cancer. Those statements describe the study rationale, not conclusions from its results.
Comparator
The comparison group received zoledronic acid alone, labelled Arm II: ZLD. The randomized parallel-group design compares assignment to the combination with assignment to the single-drug regimen. The registry does not report masking, and records the study as having no masking. Treatment adherence and any treatment changes are not reported in the registry record.
Primary question
The primary question was whether time to disease progression differed between the randomized groups. TTP was defined as the time from randomization to the earliest documentation of progression, with participants followed for a maximum of 5 years from registration. The posted median estimates were 2.4 years for the combination group and 1.2 years for the zoledronic-acid-alone group. The reported log-rank p-value was 0.02. These results describe the trial data and do not, on their own, settle how broadly the finding applies or establish a treatment recommendation.
3. Trial Design
This was a randomized phase III trial with a parallel-group design and no masking recorded in the registry. It enrolled 68 participants with early stage multiple myeloma. Arm I: Thal/ZLD included 35 participants assigned to thalidomide plus zoledronic acid; Arm II: ZLD included 33 assigned to zoledronic acid alone. The sponsor was Mayo Clinic. The record lists the study as completed.
The principal outcome was time to disease progression. The registry defines this as the time from randomization to the earliest documentation of progression and says participants were followed for a maximum of 5 years from registration. It states that the primary analysis included all randomized participants on an intent-to-treat basis. That approach retains participants in their assigned groups for analysis, regardless of whether their treatment exposure later changed, although the record does not describe such changes.
The listed primary method was Kaplan-Meier estimation of medians with 95% confidence intervals and a two-sided stratified log-rank test. The primary outcome description also contains a reference to median overall survival, although the outcome title and definition concern time to disease progression. This wording makes the record internally unclear about that phrase; the result should be read as the stated TTP outcome, not as an overall-survival result.
The registry lists secondary outcomes concerning 12-month progression-free survival, confirmed response during the first 12 months, duration of response, time to subsequent treatment, time to treatment failure, and severe adverse events. Results are posted for some, but not all, listed outcomes. The registry record does not report the allocation sequence procedure, concealment method, masking details beyond none, or a sample-size justification. It also does not report a detailed protocol or full statistical analysis plan.
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: All 68 participants were randomized.
Overall Study
| Stage | Arm I: Thal/ZLD | Arm II: ZLD |
|---|---|---|
| STARTED | 35 | 33 |
| COMPLETED | 30 | 32 |
| NOT COMPLETED | 5 | 1 |
Analysis population for the primary outcome, as defined in the registry: Time to disease progression was analyzed on all randomized participants on an intent to treat basis.
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 | Arm I: Thal/ZLD | Arm II: ZLD | Total |
|---|---|---|---|---|
| Participants analysed | 35 | 33 | 68 | |
| Age Continuous | years | 63 (47 to 84) | 63 (47 to 80) | 63 (47 to 84) |
| Sex: Female, Male: Female | Participants | 13 | 14 | 27 |
| Sex: Female, Male: Male | Participants | 22 | 19 | 41 |
| Region of Enrollment: United States | participants | 35 | 33 | 68 |
| Beta-2 Microglobulin: High (> upper limit of normal) | participants | 29 | 26 | 55 |
| Beta-2 Microglobulin: Normal (<= upper limit of normal) | participants | 6 | 7 | 13 |
| Lytic Bone Lesions: Present | participants | 2 | 2 | 4 |
| Lytic Bone Lesions: Not Present | participants | 33 | 31 | 64 |
| Bone Marrow Labeling Index: High (> 1.0%) | participants | 3 | 3 | 6 |
| Bone Marrow Labeling Index: Low (<= 1.0%) | participants | 31 | 30 | 61 |
| Bone Marrow Labeling Index: Not Applicable | participants | 1 | 0 | 1 |
| Anemia: < lower limit of normal | participants | 14 | 18 | 32 |
| Anemia: >= lower limit of normal | participants | 21 | 15 | 36 |
| Peripheral blood circulating plasma cells: Yes | participants | 13 | 14 | 27 |
| Peripheral blood circulating plasma cells: No | participants | 20 | 18 | 38 |
| Peripheral blood circulating plasma cells: Not Applicable | participants | 1 | 0 | 1 |
| Peripheral blood circulating plasma cells: Not Done | participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Disease Progression (TTP), measured over randomization to progression (up to 5 years).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | years |
| Endpoint classification | Time-to-Event Analysis |
Time to disease progression measures the interval from randomization until the earliest documented disease progression. Unlike a simple count of participants who progress by a fixed visit, a time-to-event endpoint uses the timing of progression and can account for participants whose observed follow-up ends before progression. The registry states that participants were followed for a maximum of 5 years from registration and that the analysis was conducted on all randomized participants using an intent-to-treat basis.
The median is the estimated point in the event-time distribution by which half of the participants are estimated to have experienced the event, under the Kaplan-Meier method. It describes a central point in the observed time-to-event pattern; it is not a statement that every participant progressed at that time. The 95% confidence interval conveys uncertainty around the median estimate. Overlapping confidence intervals do not replace the trial’s reported comparison test, and the interval estimates alone do not determine whether the groups differ statistically.
TTP is used when the timing of progression is a central clinical-trial question. It is distinct from overall survival, which concerns time to death, and from progression-free survival, which can use a combined event definition. The registry’s outcome title and definition specify TTP. Its description’s reference to median OS is inconsistent wording, and the record does not clarify that phrase.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The estimated median time to disease progression was 2.4 years in Arm I: Thal/ZLD, with a 95% confidence interval from 1.4 to 3.6 years. In Arm II: ZLD, the estimated median was 1.2 years, with a 95% confidence interval from 0.7 to 2.5 years. The registry reports a two-sided stratified log-rank p-value of 0.02 for the comparison. This is the sponsor-reported comparison for the primary time-to-event outcome.
The reported medians describe the estimated event-time distributions, not each participant’s experience. The confidence intervals indicate uncertainty in each median estimate. Their overlap does not negate the reported log-rank result: the log-rank test compares event-time information across the groups over follow-up, rather than testing only whether the two median point estimates are different. The record does not report a hazard ratio or its confidence interval for this comparison, so the relative event rate over time cannot be described from the posted primary result.
The result is evidence of a difference in the observed time-to-progression patterns under the trial’s analysis, at the reported p-value. A p-value is not the probability that the null hypothesis is true, nor does it quantify the size or clinical importance of the difference. The median estimates and their intervals are more directly useful for describing the observed time scale, while the log-rank test summarizes the evidence against equal event-time distributions under its assumptions.
Interpretation is bounded by the trial’s enrollment of 68 participants and the information reported in the registry. The record does not provide event counts, detailed follow-up completeness, a hazard ratio, or the handling of censoring in sufficient detail for a fuller assessment. No recalculated primary comparison is presented because the primary outcome is a median time-to-event endpoint and the posted summary statistics do not support a simple unadjusted recalculation. The sponsor’s own analysis is therefore the relevant primary comparison reported in the registry.
The secondary outcomes provide related but distinct views of disease status and treatment course. Their posted findings should not be treated as independent confirmation of the primary result, especially because the registry does not report whether multiplicity was addressed. Statistical evidence for a difference does not alone establish its practical importance, generalizability, or implications for an individual patient.
9. Statistical Methods Explained
The registry identifies time to disease progression as the primary endpoint and reports a Kaplan-Meier method for estimating its median and 95% confidence interval. It also reports a two-sided stratified log-rank test. The endpoint description states that the time origin is randomization and the event is the earliest documented disease progression. These methods are standard for a time-to-event outcome, but the record does not give enough detail to reconstruct every feature of the analysis.
What does Kaplan-Meier estimation describe?
Kaplan-Meier estimation uses the observed event times together with the timing of censoring. Censoring occurs when a participant’s event time is not observed during available follow-up, for example because observation ends before the event is documented. The method does not treat a censored participant as if the event occurred at the last observed time; it incorporates the participant’s observed time without claiming to know what happened afterward. Its interpretation depends on assumptions about how censoring relates to the event process. The registry does not report the number censored, reasons for censoring, or diagnostic checks for those assumptions.
A median estimated from a Kaplan-Meier curve is the time at which the estimated event-free proportion reaches the median threshold. It is a summary of the distribution, not an average and not a fixed follow-up time for every participant. The 95% confidence interval expresses sampling uncertainty for that estimate under the method used. A wide interval signals less precision than a narrow interval, though precision must be judged in context. The posted intervals quantify uncertainty about each group’s median; they are not a confidence interval for the difference between medians.
What does the log-rank test compare?
The log-rank test compares the event-time patterns between groups across the follow-up period. It incorporates the ordering of events and the risk sets at event times, including censoring information. The registry describes the test as two-sided and stratified. A two-sided test allows evidence in either direction; stratification means the comparison accounts for strata, but the registry record does not identify the stratification variables. The reported p-value is 0.02. It measures how incompatible the observed test statistic is with the null model of no group difference, under the test’s assumptions. It is not an estimate of the size of the difference.
The log-rank test is commonly interpreted alongside a hazard ratio when a proportional-hazards summary is available. A hazard ratio describes a relative event rate over time under a model and can be difficult to interpret if the relative event rate changes over follow-up. The registry does not post a hazard ratio for the primary comparison. No hazard-ratio estimate should be inferred from the medians or the p-value.
Why can the posted primary result not be recalculated from the summaries?
A simple unadjusted recalculation can be made for some binary outcomes when group counts are posted. A time-to-event comparison requires event-time and censoring information, or another suitable summary, that is not captured by the two medians and their separate confidence intervals. The primary endpoint’s reported comparison is therefore the registry’s log-rank analysis rather than a new calculation from the group summaries. The record reports no discrepancy between the posted primary result and a recalculation, and no recalculated primary test is available.
The registry’s primary description says the analysis was on all randomized participants on an intent-to-treat basis. This preserves the randomized group comparison and is generally intended to avoid bias from analyzing participants according to treatment received after randomization. The record does not describe how missing outcome information, deviations, or withdrawal were handled beyond that statement.
How should the binary secondary comparisons be read?
For the posted binary outcomes, the unadjusted recalculations compare observed proportions between the randomized groups. A risk difference expresses the difference in those proportions on an absolute scale, with the sign depending on the stated group order. Its confidence interval conveys uncertainty in that unadjusted estimate. The reported chi-squared tests are the registry’s own comparisons. The recalculated tests use the posted group counts and are not adjusted for covariates or for multiple outcomes.
For 12-month progression-free survival, the recalculated risk difference is reported as -0.312 for Arm II: ZLD relative to Arm I: Thal/ZLD, with a 95% confidence interval from -0.517 to -0.106. The unadjusted recalculated p-value is 0.005, while the registry reports a chi-squared p-value of 0.005. For confirmed response, the corresponding recalculated risk difference is -0.371, with a 95% confidence interval from -0.531 to -0.211; the reported and recalculated p-values are both <0.001. These are unadjusted comparisons and should not be interpreted as adjusted effects.
Over-dispersion is a general concern when a model assumes more uniform variability than the data exhibit. It can make standard errors too small and confidence intervals too narrow if ignored. The posted binary comparisons are based on simple group counts and do not report a model for over-dispersion; the relevant concern is not to retrofit a model without individual-level data or a prespecified analysis. More generally, the registry does not describe covariate adjustment, model diagnostics, missing-data methods, or a detailed analysis plan, so those aspects cannot be evaluated from the record.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Log Rank | not reported | 0.020 |
The primary comparison in the registry is the sponsor-reported two-sided stratified log-rank test for time to disease progression, with p = 0.02. The primary outcome is a median time-to-event measure. The posted medians and their confidence intervals do not contain the event-time and censoring detail needed to independently reproduce a log-rank test or derive a valid recalculated hazard ratio. The reported primary test therefore remains the analysis to interpret; no simple unadjusted recalculation is presented for it.
For the posted binary secondary outcomes, simple unadjusted recalculations from the group counts are available. For 12-month progression-free survival, the recalculated p-value is 0.005 and the registry’s chi-squared p-value is 0.005. For confirmed response, both are reported as <0.001. These small differences in the progression-free survival p-values reflect distinct calculations, not necessarily a contradiction. The registry record indicates no discrepancy requiring one result to supersede the other. The sponsor’s reported tests remain the trial’s own analyses; the recalculations are supplementary unadjusted comparisons and do not reproduce any unreported adjustment or analysis-plan decisions.
Neither set of p-values answers whether the effect is clinically important or whether the findings extend to other settings. The registry does not report a full statistical analysis plan with which to assess whether the sponsor’s analyses followed prespecified choices.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome and multiple secondary outcomes, with results posted for some of them. Testing several outcomes creates a multiplicity concern: when each test is considered separately, the overall chance of obtaining at least one small p-value by chance can increase. A prespecified hierarchy, adjustment procedure, or other strategy can address this issue, but the registry record does not report whether any such plan was used. The reported secondary p-values are therefore best treated as unadjusted evidence unless further documentation establishes otherwise.
The primary analysis is stated to include all randomized participants on an intent-to-treat basis. That is an important description of the analysis population, but it does not specify how unavailable endpoint data were handled. The registry record does not report the amount or reasons for missing outcome information, the number of participants censored, or sensitivity analyses for missingness. It also does not describe whether participants who discontinued treatment remained under outcome follow-up.
For a time-to-event endpoint, censoring is part of the analysis, and its timing and reasons can affect the interpretation of Kaplan-Meier estimates and the log-rank comparison. The registry gives a maximum follow-up duration but does not report the distribution of follow-up or how censoring was managed in detail. For binary outcomes, the posted counts give group denominators and event counts, but the record does not explain how any missing assessments were classified or whether all randomized participants had an assessment at the relevant time.
Interim analyses, stopping rules, sample-size justification, and a detailed statistical analysis plan are not reported in the registry record. Their absence from the record does not establish that they were not part of the trial documentation; it means they cannot be evaluated from these results. Without those details, the timing and prespecification of analyses and the completeness of outcome data remain uncertain.
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 |
|---|---|---|---|
| Arm I: Thal/ZLD | 3 | 35 | 8.6% |
| Arm II: ZLD | 1 | 33 | 3.0% |
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 |
|---|---|
| Arm I: Thal/ZLD | 35 of 35 |
| Arm II: ZLD | 28 of 33 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm I: Thal/ZLD | Arm II: ZLD |
|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | 1 of 35 | 0 of 33 |
| Infection without neutropenia | Infections and infestations | 1 of 35 | 0 of 33 |
| Ureteral Obstruction | Renal and urinary disorders | 1 of 35 | 0 of 33 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 35 | 0 of 33 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 35 | 0 of 33 |
| Pulmonary | Respiratory, thoracic and mediastinal disorders | 0 of 35 | 1 of 33 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm I: Thal/ZLD | Arm II: ZLD |
|---|---|---|---|
| Fatigue | General disorders | 27 of 35 | 20 of 33 |
| Peripheral sensory neuropathy | Nervous system disorders | 28 of 35 | 6 of 33 |
| Constipation | Gastrointestinal disorders | 22 of 35 | 6 of 33 |
| Depressed level of consciousness | Nervous system disorders | 18 of 35 | 1 of 33 |
| Rash/Desquamation | Skin and subcutaneous tissue disorders | 10 of 35 | 8 of 33 |
| Neutropenia | Investigations | 13 of 35 | 2 of 33 |
| Infection without neutropenia | Infections and infestations | 8 of 35 | 2 of 33 |
| Fever-No ANC | General disorders | 1 of 35 | 3 of 33 |
| Peripheral motor neuropathy | Nervous system disorders | 4 of 35 | 0 of 33 |
| Anemia | Blood and lymphatic system disorders | 2 of 35 | 1 of 33 |
Serious events with the highest arm-level rate: pulmonary (3.0%), vertigo (2.9%), infection without neutropenia (2.9%), ureteral obstruction (2.9%), cough (2.9%).
The registry reports serious adverse events affecting 3 participants in Arm I: Thal/ZLD, among 35 at risk, and 1 participant in Arm II: ZLD, among 33 at risk. These are counts of participants, not a complete description of the types, timing, duration, or attribution of every event. The record also reports other adverse events affecting 35 of 35 participants in the combination group and 28 of 33 in the zoledronic-acid-alone group. These categories should be read as recorded and should not be assumed to describe severity or causation beyond their labels.
The listed serious-event terms and percentages are Pulmonary, 3.0%; Vertigo, 2.9%; Infection without neutropenia, 2.9%; Ureteral Obstruction, 2.9%; Cough, 2.9%; and Dyspnea, 2.9%. The registry excerpt does not specify the group attribution for each term, nor does it provide enough context to determine whether participants could contribute more than one event. The percentages should not be converted into a direct comparison between arms.
These safety figures are descriptive. The groups are small, and the registry does not provide an inferential comparison, event-level exposure time, or information sufficient to assess whether events were caused by treatment. The counts alone do not establish that one regimen is safer than the other.
13. What the Result Does, and Does Not, Mean
The posted primary result describes a difference between randomized groups in the estimated time-to-progression distributions. The median estimate was 2.4 years for thalidomide plus zoledronic acid and 1.2 years for zoledronic acid alone. The reported two-sided stratified log-rank p-value was 0.02. Together, these numbers indicate that the trial observed different progression-time patterns under the analysis described in the registry.
This result does not mean that every participant in one group experienced progression later than every participant in the other group. The medians summarize group distributions, and the confidence intervals show uncertainty around those estimates. Nor does the p-value state the probability that the observed difference arose by chance, or the probability that a treatment effect exists. It is a test statistic interpreted under a null model and its assumptions.
The result does not supply a hazard ratio, a direct estimate of the difference between medians with its confidence interval, or individual-level outcome patterns. The record also does not provide enough information to assess the stability of the result under alternative censoring or missing-data assumptions. The primary description’s reference to median OS is inconsistent with the TTP title and definition, so it should not be taken as evidence about overall survival.
The secondary results describe separate outcomes and should be interpreted with the multiplicity and missing-data limitations in mind. The trial’s randomized comparison can inform understanding of the specific study groups and endpoints, but the registry information does not establish how well the findings generalize to other populations or treatment contexts. It also does not establish a benefit-harm balance or justify a treatment decision for an individual. Those conclusions require broader evidence and clinical context beyond the posted statistics.
14. Why This Trial Matters Statistically
This trial is statistically informative because its primary outcome is time-to-event, while some of its posted secondary outcomes are binary counts at a specified time or response status. The distinction matters: time-to-event methods use both whether and when an event occurs, and account for censoring, whereas a binary comparison reduces observations to outcome counts at a fixed assessment. The two types of results answer related but non-identical questions.
The primary analysis pairs group-specific Kaplan-Meier medians and confidence intervals with a stratified log-rank test. This allows readers to distinguish a descriptive summary of event timing from a formal comparison across follow-up. The reported p-value alone would not convey the magnitude or precision of the group summaries; the medians and intervals add that context. Conversely, the separate intervals are not a substitute for a confidence interval for a between-group effect.
The record also illustrates an important limit of registry summaries: a time-to-event result cannot generally be reconstructed from medians alone. Individual event and censoring times, or appropriate model estimates, are needed for further analyses such as a hazard ratio. The absence of those details means that independent recalculation is not available for the primary comparison, while simple unadjusted checks are possible for the posted binary counts.
Finally, several secondary endpoints create a multiplicity issue, and incomplete reporting of analysis plans and missing-data handling limits how confidently those findings can be ranked. These are not merely technical details: they affect how much evidential weight can be placed on individual p-values and how fully the results can be independently evaluated.
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 registry record contains limited information for assessing trial conduct and analysis. It reports randomization and a parallel design, but the sequence-generation and allocation-concealment procedures are not reported in the registry record. Masking is recorded as none. The record does not describe how this lack of masking was addressed in outcome assessment or whether progression determinations were made using blinded review.
The primary endpoint is titled time to disease progression and defined from randomization to earliest documented progression, but the description also refers to median OS. The record does not clarify this wording. The primary result should therefore be understood using the named TTP endpoint and its definition, without treating it as an overall-survival result. A hazard ratio, event counts, detailed follow-up distribution, and censoring details are not reported in the registry record.
The enrollment was 68 participants. The record does not report the basis for choosing that enrollment, a sample-size justification, interim analyses, stopping rules, or a detailed statistical analysis plan. It also does not report the multiplicity strategy for secondary outcomes. These omissions limit assessment of the intended precision and the prespecification of the reported analyses.
Missing-data amounts and handling are not reported in the registry record. Although the primary population is identified as all randomized participants on an intent-to-treat basis, the record does not explain how withdrawals, unavailable assessments, or incomplete follow-up affected the endpoint analyses. The adverse-event summary is also limited: attribution, event timing, exposure-adjusted comparisons, and group attribution for the listed terms are not sufficiently described. These limitations constrain interpretation; they do not by themselves show that trial procedures were inadequate.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma — NCT00432458.
- Registry record last updated 2012-07-04; status last verified 2012-06.
- Results first posted 2012-07-04.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT00432458 is a completed randomized phase III parallel-group trial sponsored by Mayo Clinic. It enrolled 68 participants with early stage multiple myeloma and compared thalidomide plus zoledronic acid with zoledronic acid alone. The registry records no masking.
The primary outcome was time to disease progression, defined from randomization to the earliest documented progression. The estimated medians were 2.4 years for Arm I: Thal/ZLD and 1.2 years for Arm II: ZLD, with respective 95% confidence intervals of 1.4 to 3.6 years and 0.7 to 2.5 years. The sponsor-reported stratified log-rank p-value was 0.02. The primary population was all randomized participants on an intent-to-treat basis.
Secondary results include 12-month progression-free survival and confirmed response; the registry also lists additional response, treatment-course, and safety outcomes. Interpretation is limited by missing details on the statistical plan, multiplicity, missing data, censoring, and the internal TTP/OS wording inconsistency.