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 Fresolimumab and Radiotherapy in Metastatic Breast Cancer (NCT01401062), a randomized phase 2 study. The primary outcome is Abscopal Response Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01401062 |
| Phase | Phase 2 |
| Condition | Metastatic Breast Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 23 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Weill Medical College of Cornell University |
| Results posted | Yes |
2. Clinical Question
Population
People with metastatic breast cancer were studied. The registry record lists an enrollment of 23. Eligibility details beyond the condition are not reported in the registry record, so the record does not establish which clinical or demographic characteristics defined the study population.
Intervention
One arm received fresolimumab at 1 mg/kg with local radiotherapy. Fresolimumab was administered intravenously on day 1 of weeks 0, 3, 6, 9 and 12. Radiation was administered at 7.5 Gy/fraction in 3 fractions during weeks 1 and 7, directed to lesion 1 and lesion 2, respectively.
Comparator
The other arm received the same described radiotherapy schedule with fresolimumab at 10 mg/kg. The comparison therefore concerns the two fresolimumab dose regimens in the setting of local radiation, not fresolimumab versus no fresolimumab or radiation versus no radiation.
Primary question
The registry asks about the abscopal response rate: the percentage of patients with a complete or partial response outside irradiated lesions. It says this response is assessed at 15 weeks and confirmed a minimum of 4 weeks later, using immune-related response criteria. The posted results report participant counts, not percentages.
3. Trial Design
This was a phase 2, randomized, parallel-group study with no masking, listed as completed. The sponsor was Weill Medical College of Cornell University. The registry lists the study start as 2011-07 and primary completion as 2014-06. Enrollment was 23. The registry reports 11 participants in the 1 mg/kg arm and 12 in the 10 mg/kg arm.
Both arms combined fresolimumab with local radiotherapy. The regimen descriptions specify intravenous fresolimumab on day 1 of weeks 0, 3, 6, 9 and 12. Radiation was given at 7.5 Gy/fraction in 3 fractions during weeks 1 and 7, to lesion 1 and lesion 2. The stated distinction between the arms is the fresolimumab dose: 1 mg/kg or 10 mg/kg.
Random allocation and parallel treatment groups support a direct comparison of the assigned dose regimens, but the record does not report how the allocation sequence was generated or concealed. Masking is listed as none. Whether outcome assessors were masked separately is not reported in the registry record. Details of eligibility criteria, treatment adherence, protocol deviations, and participant flow are also not reported in the registry record.
The primary outcome is an abscopal response, defined in the record as a complete or partial response outside the irradiated lesions. Its timeframe is up to 20 weeks; the description specifies assessment at 15 weeks and confirmation a minimum of 4 weeks later. The record identifies immune-related response criteria as the assessment basis. It does not report the statistical analysis plan or explain whether the posted comparison follows an intention-to-treat, per-protocol, or other analysis population.
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 | Arm 1 (Fresolimumab 1 mg/kg) | Arm 2 (Fresolimumab 10 mg/kg) |
|---|---|---|
| STARTED | 11 | 12 |
| COMPLETED | 0 | 4 |
| NOT COMPLETED | 11 | 8 |
Reasons for not completing this period:
| Reason | Arm 1 (Fresolimumab 1 mg/kg) | Arm 2 (Fresolimumab 10 mg/kg) |
|---|---|---|
| Death | 9 | 7 |
| Physician Decision | 1 | 0 |
| Withdrawal by Subject | 1 | 1 |
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 1 (Fresolimumab 1 mg/kg) | Arm 2 (Fresolimumab 10 mg/kg) | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 12 | 23 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 9 | 7 | 16 |
| Age, Categorical: >=65 years | Participants | 2 | 5 | 7 |
| Sex: Female, Male: Female | Participants | 11 | 12 | 23 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Asian or Pacific Islander | participants | 1 | 3 | 4 |
| Race/Ethnicity, Customized: Black, not of Hispanic-American Origin | participants | 3 | 0 | 3 |
| Race/Ethnicity, Customized: White, not of Hispanic-American origin | participants | 6 | 8 | 14 |
| Race/Ethnicity, Customized: Other/Unknown | participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Abscopal Response Rate, measured over up to 20 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the abscopal response rate, described as the percentage of patients with a complete or partial response outside irradiated lesions. In this study, that outcome concerns lesions other than those directly treated with radiation. The registry describes assessment at 15 weeks and confirmation a minimum of 4 weeks later, using immune-related response criteria.
An endpoint of this kind is used to operationalize a clinical question in a way that can be counted and compared across assigned groups. A response outside the irradiated areas distinguishes the endpoint from a response confined to treated lesions. This is a definition of what the endpoint attempts to capture, not evidence about the biological mechanism or a claim that any response was caused by a particular treatment.
The results are posted as counts of participants: 11 in the 1 mg/kg arm and 12 in the 10 mg/kg arm. The registry record does not post percentages for the arm outcomes. Although it defines the outcome as a percentage, a reader should not treat the count display as a percentage or assume that the posted counts resolve details about missing assessments or evaluability. Those details are not reported in the registry record.
7. Results Posted in the Registry
- Arm 2 (Fresolimumab 10 mg/kg): 100.0% (12/12) versus 100.0% (11/11) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0), risk ratio 1.00 (1.00–1.00); unadjusted two-proportion z-test p = n/a.
Risk difference: Arm 2 (Fresolimumab 10 mg/kg)
95% CI: 0.0 to 0.0 percentage points
Recalculated from the posted summary statistics
8. Statistical Interpretation
The posted primary outcome records 11 participants with an abscopal response in the fresolimumab 1 mg/kg arm and 12 in the fresolimumab 10 mg/kg arm. The arm sizes recorded alongside these counts are 11 and 12, respectively. The reported risk difference for the 10 mg/kg arm relative to the 1 mg/kg arm is 0.0, with reported bounds of 0.0 and 0.0. These values describe the posted comparison; they do not establish that the dose regimens are equivalent or that the endpoint is measured without uncertainty.
The matching arm counts and response counts are a notable feature of the registry result, but the record does not explain the analysis population or how participants without an assessable response, if any, were handled. It also does not give a separate account of missing outcome data. Consequently, the recorded counts cannot answer whether all randomized participants contributed evaluable endpoint data or whether the posted endpoint count was determined under another rule.
The record reports no posted statistical analyses beyond the outcome and comparison information reflected in the results. It does not report an analysis method, a test statistic, a p-value, an adjustment strategy, or a prespecified statistical plan. The comparison bounds are identical to the point estimate. Without a reported method or further analysis details, that interval should be read literally as the bounds recorded, rather than as evidence that the underlying response difference is known with certainty.
The study was randomized, which is relevant to interpreting between-arm comparisons, but randomization alone does not answer questions about the execution of allocation, follow-up, outcome assessment, or analysis. Masking is listed as none, and the record does not report separate masking of response assessors. These design and reporting details matter particularly for an outcome requiring assessment of lesions and confirmation of response.
The outcome is specific to response outside irradiated lesions, and the study combines fresolimumab with radiotherapy in both groups. The posted contrast is therefore between the two dose regimens within that treatment context. It does not estimate the effect of fresolimumab compared with no fresolimumab, the effect of radiotherapy compared with no radiotherapy, or the effect of the combination compared with another treatment strategy.
The registry also reports serious adverse-event counts by arm, but those counts are separate safety summaries and should not be read as evidence about the primary response endpoint. The available record supports a descriptive reading of the reported outcome counts and comparison. It does not report enough statistical detail to establish the stability, generalizability, or causal interpretation of the endpoint result beyond this randomized study.
9. Statistical Methods Explained
The registry describes a randomized, parallel-group design. In general, randomization is intended to make assigned groups comparable with respect to both measured and unmeasured characteristics, apart from chance variation. It can strengthen interpretation of a treatment contrast when allocation is implemented appropriately and participants are analyzed in a way consistent with the randomized assignment. The record does not report the sequence-generation or allocation-concealment methods, so those implementation details cannot be assessed.
What does the between-arm contrast represent?
The stated comparison is the risk difference for the fresolimumab 10 mg/kg arm relative to the 1 mg/kg arm. In general, a risk difference expresses the difference between the outcome proportions in two groups. Its value of 0.0 indicates that the reported estimate of the difference is zero on that scale. The response counts also match the recorded group sizes. These summaries describe the endpoint as posted, but do not by themselves identify the analysis population or account for outcome data that may be unavailable.
The contrast is dose-specific: both groups received fresolimumab and radiotherapy. It is not a comparison with an untreated group. This distinction is important because a between-arm estimate can only address the contrast represented by its assigned regimens, subject to the study's conduct and analysis. It cannot separate the contribution of radiotherapy from fresolimumab when both are present in each arm.
How should the interval be read?
A confidence interval is a statistical range constructed by a method to express uncertainty around an estimate. In general, its width reflects both the variability in the observed data and the method used to calculate the interval. The registry gives a risk-difference estimate of 0.0 and bounds of 0.0 and 0.0. It does not report the interval method, its confidence level, or supporting analysis details. The recorded bounds therefore should not be interpreted as demonstrating absence of uncertainty. Nor can the interval be independently assessed from the information reported.
Small clinical studies can produce imprecise estimates, especially for binary outcomes, because the possible counts are limited and a small change in observed outcomes can affect the estimated proportion. This is general statistical context, not a numerical conclusion about a particular confidence level or precision in this study. The unusual appearance of identical point estimate and bounds makes the absent method especially relevant; it is not appropriate to infer why the values coincide.
What can be inferred from counts?
For a binary endpoint, each participant is categorized according to whether the event is recorded. Counts are directly interpretable as numbers of participants with the event, while proportions relate those counts to a defined denominator. The registry labels the outcome as a percentage but posts participant counts. The counts align with the stated arm sizes, yet the record does not explain whether those arm sizes are the denominators used for the endpoint analysis, or how any unevaluable or missing results were treated. No percentages should be substituted for the posted count results without a clearly specified analysis population.
In general, a binary endpoint can be analyzed with methods that estimate group risks, risk differences, risk ratios, or odds ratios. The record's stated comparison metric is risk difference. It does not state which statistical procedure produced the estimate or bounds. It would therefore be unsupported to label the result as coming from a particular test, regression model, continuity correction, or exact procedure. The registry does not report an adjusted estimate or covariate adjustment plan.
What do the planning illustrations mean?
The record describes sample-size calculations as planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not a report of the study's original design justification. The record does not report the original sample-size rationale or a target enrollment justification.
Such calculations are general design tools: they illustrate the number of participants per arm that a hypothetical future study might require under stated assumptions. They are not observed power, do not establish the probability that the study detected an effect, and do not replace uncertainty intervals around the observed result. Because the estimate in this record is 0.0, the choice of an effect fraction and the details of the calculations should be interpreted in light of the stated planning method; no additional sample-size result is described.
In general, power is a prospective property of a planned design under assumed effects and variability. It cannot be used after the fact as a measure of whether a trial result is true, nor does it correct for missing data, outcome assessment concerns, or imprecision. The record does not report interim analyses, stopping rules, a multiplicity strategy, or a detailed statistical analysis plan. Those elements should not be inferred from the planning assumptions.
10. Confidence Intervals and Precision
The posted risk-difference estimate is 0.0, and the registry records bounds of 0.0 and 0.0. A confidence interval is generally used to convey the uncertainty associated with an estimate under a specified statistical method. The registry does not identify the method or confidence level for these bounds. Because the lower and upper bounds equal the estimate as reported, the interval cannot be evaluated as a conventional summary of uncertainty without those details.
The outcome counts are 11 of 11 recorded for the 1 mg/kg arm and 12 of 12 for the 10 mg/kg arm, based on the arm counts and endpoint counts in the record. This statement describes the entries, not a recalculated percentage or a claim that every randomized participant had an evaluable response. The record does not describe missing assessments, the analysis denominator, or the handling of unevaluable outcomes. The meaning of the count-to-arm-size correspondence is therefore limited by absent analysis-population information.
In general, precision depends on the amount of information in the data, the outcome frequency, and the method used for inference. A small study can leave substantial uncertainty even when the observed group summaries look alike. That general principle does not supply a corrected interval or quantify uncertainty for this trial. No such recalculation is warranted from the registry entries alone.
The sample-size calculations are planning illustrations based on the observed effect and stated assumptions. They are not a substitute for an interval around the observed contrast and should not be read as observed power. The registry does not report a justification for the original enrollment or the precision target intended at design. Accordingly, the posted point estimate is best read descriptively, with the interval's interpretation constrained by the lack of a stated method.
11. Multiplicity, Missing Data and Analysis Populations
The registry posts one primary outcome measure and reports no secondary outcomes. It records no analyses. A multiplicity plan—how statistical interpretation would account for testing multiple outcomes, contrasts, time points, or interim looks—is not reported in the registry record. The record also does not state whether any analyses beyond the posted primary comparison were planned or conducted. It would be inappropriate to infer either that multiplicity was addressed or that no additional analyses occurred.
Missing data handling is not reported in the registry record. In particular, the record does not describe whether all randomized participants were included in the primary analysis, how a participant with no assessable response was categorized, or whether the endpoint required a confirmed response for inclusion. The outcome description says response is assessed at 15 weeks and confirmed a minimum of 4 weeks later, but it does not explain how unavailable assessments or incomplete confirmation were handled.
The analysis population is not reported in the registry record. The posted counts match the stated sizes of the arms, but that correspondence alone does not identify whether the analysis followed randomized assignment, treatment received, or an evaluability rule. The registry also does not report a participant-flow account, protocol deviations, or exclusions from analysis.
These omissions affect how the count comparison should be interpreted. An explicit prespecified plan, analysis population, missing-data rule, and accounting of outcome assessments would help readers understand which participants contributed to the endpoint and how the estimate was produced. Their absence does not show that a particular method was or was not used; it means that these details cannot be established from the registry record.
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 1 (Fresolimumab 1 mg/kg) | 3 | 11 | 27.3% |
| Arm 2 (Fresolimumab 10 mg/kg) | 3 | 12 | 25.0% |
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 1 (Fresolimumab 1 mg/kg) | 9 of 11 |
| Arm 2 (Fresolimumab 10 mg/kg) | 8 of 12 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm 1 (Fresolimumab 1 mg/kg) | Arm 2 (Fresolimumab 10 mg/kg) |
|---|---|---|---|
| Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 11 | 2 of 12 |
| atrial fibrillation | Cardiac disorders | 2 of 11 | 0 of 12 |
| Hypercalcemia | Endocrine disorders | 1 of 11 | 1 of 12 |
| Dyspnea | Immune system disorders | 0 of 11 | 1 of 12 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 0 of 11 | 1 of 12 |
| Cord compression | Nervous system disorders | 1 of 11 | 0 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm 1 (Fresolimumab 1 mg/kg) | Arm 2 (Fresolimumab 10 mg/kg) |
|---|---|---|---|
| Fatigue | General disorders | 3 of 11 | 2 of 12 |
| Disease Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 11 | 2 of 12 |
| Aspartate Aminotransferase Increased | Investigations | 3 of 11 | 0 of 12 |
| hypercalcemia | Metabolism and nutrition disorders | 1 of 11 | 1 of 12 |
| Alkaline Phosphate Increased | Investigations | 2 of 11 | 0 of 12 |
| Thrombocytopenia | Blood and lymphatic system disorders | 2 of 11 | 0 of 12 |
| Anemia | Blood and lymphatic system disorders | 1 of 11 | 1 of 12 |
| Hypocalcemia | Metabolism and nutrition disorders | 1 of 11 | 1 of 12 |
| Bilaterial Effusion | Musculoskeletal and connective tissue disorders | 1 of 11 | 0 of 12 |
| Cord compression | Nervous system disorders | 1 of 11 | 0 of 12 |
Serious events with the highest arm-level rate: atrial fibrillation (18.2%), disease progression (18.2%), hypercalcemia (9.1%), cord compression (9.1%), dyspnea (8.3%).
The registry reports serious adverse events affecting 3 participants in the 1 mg/kg arm and 3 participants in the 10 mg/kg arm. It separately reports other adverse events affecting 9 participants in the 1 mg/kg arm and 8 participants in the 10 mg/kg arm. These are participant counts within each group. They are not a comparison of event severity, and the record does not provide a statistical safety comparison.
The registry's serious-event term list gives atrial fibrillation and Disease progression at 18.2% each; Hypercalcemia and Cord compression at 9.1% each; and Dyspnea and Pleural effusion at 8.3% each. The listing does not state an arm alongside each term in the information reported, so those percentages should not be assigned to a particular arm. The record does not specify the denominators or clarify whether participants could contribute to more than one term.
Deaths are not reported in the registry record. Adverse-event counts describe events recorded during the study; by themselves they do not establish that an event was caused by treatment. The safety summaries should be interpreted separately from the abscopal response outcome.
13. What the Result Does, and Does Not, Mean
The posted primary result describes an abscopal response count of 11 in the fresolimumab 1 mg/kg arm and 12 in the fresolimumab 10 mg/kg arm. The recorded risk difference is 0.0, with bounds recorded as 0.0 and 0.0. This is a descriptive account of the registry's outcome and comparison. It does not establish equivalence between dose regimens, prove that their effects are identical, or show that either regimen has a particular effect relative to no treatment.
The study compares two dose regimens, each given with local radiotherapy. It cannot isolate the effect of fresolimumab from the effect of radiotherapy because there is no radiotherapy-only or fresolimumab-only comparison described. Nor does the posted result answer how the combination compares with another treatment strategy. The endpoint concerns response outside the irradiated lesions, as defined in the registry, and is not a general measure of every aspect of disease status.
Although the study is randomized, the record does not report details of allocation implementation, analysis populations, missing outcomes, or the statistical method for the comparison interval. Masking is listed as none. The record's compact outcome entry therefore does not establish the full pathway from assignment to response assessment and analysis. In particular, the equality of the recorded counts and group sizes should not be taken as proof that no participants lacked assessable outcomes.
The confidence interval bounds are reported as identical to the point estimate, but the registry does not state the method or confidence level. This prevents a conventional assessment of how precisely the underlying contrast is estimated. The posted result should not be treated as a definitive demonstration of no difference, and no medical recommendation follows from this statistical description.
The safety record reports serious-event counts and other adverse-event counts by arm, plus a list of serious-event terms and percentages. Those data provide a limited description of recorded safety events; they do not establish causality or a comparative safety profile. Deaths are not reported in the registry record. The overall interpretation remains bounded by the small enrollment, absent analysis details, and the specific endpoint and treatment comparison recorded.
14. Why This Trial Matters Statistically
This trial is statistically interesting because it compares two active dose regimens in a randomized parallel design while using an endpoint focused on response outside irradiated lesions. That makes the treatment contrast specific: it concerns fresolimumab dose in the context of radiotherapy. Recognizing exactly what the comparison represents is essential to avoid attributing the observed contrast to a component that the study did not vary between arms.
The posted response counts match the recorded arm sizes, and the reported risk difference is 0.0. Such a result makes clear why estimates need to be read alongside their uncertainty and the method used to calculate it. The interval is recorded with bounds of 0.0 and 0.0, but the method and confidence level are not reported. Statistical interpretation therefore depends not only on the point estimate, but also on transparent reporting of how uncertainty and analysis populations were handled.
The registry's planning assumptions also illustrate a general distinction in biostatistics: a sample-size calculation for a hypothetical design is not evidence about the realized precision of a completed study. The record describes its calculations as planning illustrations based on the observed effect. Those figures should not be mistaken for observed power or for the original study's design rationale.
Finally, the endpoint requires response assessment and confirmation, while the record does not explain missing assessments or evaluability. That gap highlights the importance of reporting participant flow, outcome ascertainment, analysis populations, and the prespecified statistical plan. These details allow readers to connect the clinical definition of an endpoint to the numerical estimate and judge what the result can support.
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 gives limited detail about the trial's conduct and statistical analysis. Although allocation is listed as randomized, the method for sequence generation and concealment is not reported. Masking is listed as none, and the record does not clarify whether response assessors were masked. Since the primary endpoint involves assessment of responses outside irradiated lesions and later confirmation, the absence of assessor and adjudication details limits evaluation of outcome ascertainment.
The endpoint description specifies assessment at 15 weeks and confirmation a minimum of 4 weeks later, with a timeframe of up to 20 weeks. The registry does not report how incomplete assessments, missing confirmation, or unevaluable responses were handled. It also does not identify the analysis population or explain the relationship between the posted participant counts and all randomized participants. A participant-flow account and explicit denominator rules are not reported in the registry record.
The comparison is reported as a risk difference with bounds matching the point estimate, but the confidence-interval method, confidence level, and analysis procedure are not reported. No statistical analysis plan, covariate adjustment strategy, multiplicity approach, or interim-analysis details are reported. The record does not give an original sample-size justification; the described calculations are planning illustrations based on the observed effect.
The study enrollment was 23, and the posted result is specific to the listed dose regimens, radiotherapy schedule, population, and endpoint. The record does not provide enough information to assess broader applicability, treatment adherence, protocol deviations, or longer-term outcomes. These limitations concern what can be concluded from the registry entry; they do not establish that unreported procedures were absent or that the study's conduct was deficient.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Fresolimumab and Radiotherapy in Metastatic Breast Cancer — NCT01401062.
- Registry record last updated 2019-03-05; status last verified 2019-02.
- Results first posted 2017-04-06.
- 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
The registry describes a completed phase 2 randomized, unmasked, parallel study of fresolimumab with local radiotherapy in metastatic breast cancer. The arms used fresolimumab at 1 mg/kg or 10 mg/kg, with the same radiation schedule. Enrollment was 23; the registry lists 11 participants in the lower-dose arm and 12 in the higher-dose arm.
The primary endpoint was abscopal response, defined as complete or partial response outside irradiated lesions, assessed at 15 weeks and confirmed a minimum of 4 weeks later. Posted counts are 11 and 12, respectively. The reported risk difference is 0.0, with bounds of 0.0 and 0.0. The method for the interval, analysis population, and missing-data handling are not reported in the registry record.
Serious adverse events affected 3 participants in each arm; other adverse events affected 9 and 8 participants, respectively. Deaths are not reported in the registry record. These findings are descriptive and specific to the posted study comparison.