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 Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012) (NCT00931606), a randomized phase 2 study. The primary outcome is Percentage of Participants Who Achieved a Hematopoietic Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00931606 |
| Phase | Phase 2 |
| Condition | Chemotherapy Induced Anemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Participants had chemotherapy-induced anemia and metastatic breast cancer. The primary outcome population was defined as randomized participants with confirmed chemotherapy-induced anemia who received at least one dose of study intervention and remained on study intervention for at least 2 months (57 days). This definition is narrower than enrollment alone: it includes specific requirements for confirmation, treatment exposure, and time on intervention.
Intervention
The active intervention was sotatercept given subcutaneously in one of three dose regimens: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg. Each regimen was scheduled every 28 days for up to 4 doses.
Comparator
The comparator was placebo, also given subcutaneously every 28 days for up to 4 doses. Random assignment and masking were part of the study design; the registry record does not identify who was included in the quadruple masking.
Primary question
The study asked what percentage of participants in each dose regimen achieved a hematopoietic response during treatment and through up to 2 months after the last dose. A response required hemoglobin to increase by at least 1 g/dL from baseline for 28 consecutive days, without red blood cell transfusion or treatment with an erythropoiesis-stimulating agent. The registry record does not report the primary response results, so it does not establish the observed response percentage in any arm or a comparison between arms.
3. Trial Design
The registry describes a phase 2, randomized, double-blind, placebo-controlled, parallel study of sotatercept for chemotherapy-induced anemia in participants with metastatic breast cancer. The official title identifies the study intervention as ACE-011; the registry also names the intervention sotatercept. Enrollment was 30. The study is listed as terminated. Its recorded start date was 2009-06-01, and its primary completion date was 2010-11-18.
Participants were assigned to one of three sotatercept dose regimens or placebo. Sotatercept doses were 0.1 mg/kg, 0.3 mg/kg, and 0.5 mg/kg, each given subcutaneously every 28 days for up to 4 doses. Placebo was given by the same route and schedule. The registry describes masking as quadruple, but does not report which roles or groups were masked. The record does not describe the method used to generate or conceal assignments, nor does it report the number assigned to each treatment group for the primary outcome.
The primary outcome was the percentage achieving a defined hematopoietic response. Its stated timeframe was baseline and up to approximately 145 days, with response assessment extending during treatment and up to 2 months after the last dose. The population specified for this outcome comprised randomized participants with confirmed chemotherapy-induced anemia who received at least one dose and remained on intervention for at least 2 months (57 days).
The record lists 22 outcome measures and 36 analyses. Secondary outcomes included adverse events, discontinuation because of an adverse event, additional hemoglobin thresholds, and duration of response at different thresholds. Although the study is identified as terminated, the registry record does not report a reason for termination or explain whether termination affected follow-up or outcome reporting.
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 | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| STARTED | 8 | 10 | 7 | 5 |
| COMPLETED | 3 | 1 | 1 | 2 |
| NOT COMPLETED | 5 | 9 | 6 | 3 |
Reasons for not completing this period:
| Reason | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Death | 1 | 3 | 2 | 0 |
| Lost to Follow-up | 0 | 1 | 0 | 0 |
| Physician Decision | 0 | 0 | 3 | 0 |
| Sponsor Decision | 1 | 4 | 0 | 2 |
| Withdrawal by Subject | 3 | 1 | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).
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 | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 8 | 10 | 7 | 5 | 30 | |
| Age, Continuous | Years | 51.6 (SD 9.38) | 50.8 (SD 8.51) | 55.6 (SD 12.53) | 49.2 (SD 10.62) | 51.9 (SD 9.83) |
| Sex: Female, Male: Female | Participants | 8 | 10 | 7 | 5 | 30 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 8 | 10 | 7 | 4 | 29 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Weight | Kilograms | 67.38 (SD 18.338) | 71.80 (SD 9.500) | 69.94 (SD 9.953) | 79.62 (SD 9.926) | 71.49 (SD 12.647) |
| Chemotherapy Frequency: Weekly | Participants | 2 | 2 | 1 | 1 | 6 |
| Chemotherapy Frequency: Less Frequently | Participants | 6 | 8 | 6 | 4 | 24 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Who Achieved a Hematopoietic Response, measured over Baseline and Up to ~145 Days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was the percentage of participants who achieved a hematopoietic response. For this study, response meant an increase in hemoglobin of at least 1 g/dL relative to baseline, sustained for 28 consecutive days during treatment or through up to 2 months after the last dose. The response also had to occur without red blood cell transfusion or treatment with an erythropoiesis-stimulating agent.
This definition combines the size of a change with its duration and specifies circumstances that would prevent counting the change as a response. It is therefore not simply a measurement of hemoglobin at one visit. A participant either met the full response definition or did not, and the endpoint expresses the proportion meeting it within the defined analysis population. The registry specifies a 95% confidence interval for this percentage, which would describe the statistical precision of the estimated response proportion.
The endpoint was intended to assess hematopoietic response across the treatment period and follow-up window, rather than a single immediate hemoglobin reading. However, the registry record does not report the observed response percentages or their confidence intervals. It also does not provide the results by dose regimen, so the primary endpoint cannot be interpreted as evidence for or against a difference among the study arms.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically defined primary endpoint but does not report its results. No response percentages, confidence intervals, or primary outcome comparisons are given. Consequently, the record does not show how often participants met the response definition in any sotatercept dose regimen or in the placebo group. It also does not support a statistical conclusion about differences between those groups.
The primary outcome was binary at the participant level: the response definition was either met or not met. The reported measure was the percentage of the analysis population meeting that definition, with a 95% confidence interval specified as the measure of uncertainty. In general, a confidence interval indicates a range of values compatible with the observed data under the statistical method used. Its width depends in part on the amount of information available. Here, no interval estimates are reported, so precision cannot be evaluated from the registry record.
The enrolled study size was 30, but the primary outcome population had additional eligibility and exposure requirements. It included randomized participants with confirmed chemotherapy-induced anemia who received at least one dose and stayed on intervention for at least 2 months (57 days). The record does not give the number meeting those criteria in each arm or explain how participants who did not meet them were handled in outcome analyses. Enrollment alone therefore cannot be treated as the denominator for the primary endpoint.
Safety information is reported separately. Serious adverse events were recorded in the sotatercept 0.1 mg/kg, 0.3 mg/kg, and 0.5 mg/kg groups and in the placebo group. Counts of participants with other adverse events and deaths are also listed. Those data describe the recorded safety experience, but they do not provide the primary efficacy results. The registry record does not report whether adverse events or deaths were considered related to study intervention, and the counts alone cannot establish causation.
The study was randomized and placebo-controlled, features that can support a comparative interpretation when outcome results and methods are reported. But the existence of randomization does not substitute for the missing outcome estimates. The registry record does not provide a statistical analysis plan, detailed allocation procedures, or a reported primary comparison. It is therefore not possible to assess from this record how the primary analysis was conducted or whether it followed a prespecified plan.
Because the record lists several outcome measures and analyses, a reader should distinguish the prespecified primary question from secondary findings and avoid treating any one safety count as a complete account of the study. The primary response outcome, its uncertainty, and a direct comparison among treatment groups are not reported in the registry record. The available information supports description of the design, endpoint definition, and selected safety counts, but not a conclusion about the comparative response results.
9. Statistical Methods Explained
What does the primary percentage represent?
The endpoint is a participant-level binary outcome. A participant is counted as having a hematopoietic response only when the hemoglobin increase meets the stated threshold, remains present for the required consecutive period, and occurs without red blood cell transfusion or erythropoiesis-stimulating agent treatment. The percentage expresses how common that defined outcome was among the participants included in the analysis. It does not describe the average hemoglobin change, and it does not by itself show how long a response lasted beyond the minimum duration required by the definition.
For this endpoint, the registry specifies a population of randomized participants with confirmed chemotherapy-induced anemia who received at least one dose and were on study intervention for at least 2 months (57 days). That population definition matters because a percentage depends on who is included in its denominator. The record does not report how many participants in each arm met these requirements or how missing outcome information was handled.
How should a confidence interval be read?
The registry states that the primary percentage is reported with a 95% confidence interval. In general, a confidence interval expresses statistical uncertainty around an estimate using a specified method. A relatively narrow interval indicates greater precision than a wider interval, while a wide interval signals that a range of underlying values remains compatible with the data. A confidence interval does not remove uncertainty, and it is not a guarantee that a particular value is true.
No primary response estimate or confidence interval is reported in the registry record. Thus, the precision of the endpoint cannot be assessed, and no interval-based comparison between the sotatercept regimens and placebo can be described. A confidence interval for a single arm's response percentage would also answer a different question from an interval for a difference between arms.
What does randomization contribute?
In general, random allocation aims to make treatment groups comparable with respect to measured and unmeasured characteristics on average. This supports a fair comparison, but it does not guarantee that groups will be balanced in a small study, nor does it correct problems caused by missing outcomes or deviations from the assigned intervention. A placebo comparator can help distinguish changes associated with study participation and time from changes associated with the active intervention, provided outcomes are collected and analyzed appropriately.
The registry labels the study randomized, double-blind, and quadruple-masked. It does not describe sequence generation, allocation concealment, or which parties were masked. Those details are relevant when assessing the practical protection against selection and assessment bias, but they are not reported in the registry record.
Why is the response definition more than a hemoglobin threshold?
The threshold is paired with a duration requirement: the increase must persist for 28 consecutive days. It is also qualified by the absence of transfusion or erythropoiesis-stimulating agent treatment. These conditions make the endpoint a sustained response under specified circumstances, rather than any increase at any visit. In general, such rules can make an outcome more clinically interpretable, while also making it dependent on complete and consistently timed observations. The registry does not report the visit schedule or the detailed rules used to determine response when measurements were missing or interrupted.
How should multiple outcomes and analyses be considered?
The record lists 22 outcome measures and 36 analyses. In general, examining multiple outcomes or comparisons creates more opportunities for apparently notable findings to arise by chance, especially if each is assessed separately. Statistical approaches can address multiplicity, but the registry record does not report whether adjustment was planned or used. It also does not report p-values for the primary outcome, a detailed model, or the handling of repeated assessments.
The record includes a planning illustration assumption based on a fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such illustrations are planning exercises, not observed power and not evidence that the original study was designed with those assumptions. The registry record does not report the trial's own sample-size justification or statistical planning details.
What cannot be inferred from the available methods information?
The registry provides the endpoint definition, analysis-population description, and confidence-interval label, but not the primary results or a full statistical analysis plan. The exact method for constructing confidence intervals, the approach to missing data, the handling of participants who discontinued intervention, and any sensitivity analyses are not reported in the registry record. Without those details and the outcome estimates, it is not possible to evaluate model assumptions, reproduce the analysis, or assess the robustness of the primary comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 22 outcome measures and 36 analyses. The primary outcome concerns a sustained hemoglobin response, while secondary measures include adverse events, discontinuation due to an adverse event, additional hemoglobin thresholds, and response duration. When a study evaluates multiple outcomes or treatment comparisons, the chance of at least one apparently notable result can increase if each is assessed independently. In general, multiplicity procedures can control or describe that issue. Whether any such procedure was prespecified or applied is not reported in the registry record.
The record does not report a full statistical analysis plan, interim analyses, or the method used for the primary comparison. It specifies a 95% confidence interval for the primary percentage, but does not identify the interval method. No primary response results or p-values are reported, so there is no reported primary estimate to assess alongside the multiplicity information.
The primary endpoint population is described as randomized participants with confirmed chemotherapy-induced anemia who received at least one dose of study intervention and stayed on intervention for at least 2 months (57 days). The record does not report how many participants met that definition in each arm, how participants who discontinued before that period were treated in the analysis, or whether all randomized participants were included in any separate analysis. This limits assessment of the population actually contributing to the primary result.
Rules for missing hemoglobin measurements, incomplete follow-up, and missing response status are not reported in the registry record. The record also does not describe sensitivity analyses or imputation. These omissions matter because response requires a threshold to be maintained for a consecutive period; incomplete observation can affect whether the full definition can be evaluated. The registry record does not report how those situations were addressed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | 0 | 8 | 0.0% |
| Sotatercept 0.3 mg/kg | 2 | 10 | 20.0% |
| Sotatercept 0.5 mg/kg | 3 | 7 | 42.9% |
| Placebo | 1 | 5 | 20.0% |
| Total | 6 | 30 | 20.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sotatercept 0.1 mg/kg | 1 of 8 |
| Sotatercept 0.3 mg/kg | 3 of 10 |
| Sotatercept 0.5 mg/kg | 3 of 7 |
| Placebo | 0 of 5 |
| Total | 7 of 30 |
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 |
|---|---|
| Sotatercept 0.1 mg/kg | 6 of 8 |
| Sotatercept 0.3 mg/kg | 7 of 10 |
| Sotatercept 0.5 mg/kg | 7 of 7 |
| Placebo | 5 of 5 |
| Total | 25 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 0 of 8 | 1 of 10 | 2 of 7 | 0 of 5 | 3 of 30 |
| Vomiting | Gastrointestinal disorders | 0 of 8 | 1 of 10 | 2 of 7 | 0 of 5 | 3 of 30 |
| Dehydration | Metabolism and nutrition disorders | 0 of 8 | 1 of 10 | 1 of 7 | 0 of 5 | 2 of 30 |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 8 | 1 of 10 | 1 of 7 | 0 of 5 | 2 of 30 |
| Anaemia | Blood and lymphatic system disorders | 0 of 8 | 0 of 10 | 1 of 7 | 0 of 5 | 1 of 30 |
| Gastric ulcer perforation | Gastrointestinal disorders | 0 of 8 | 0 of 10 | 1 of 7 | 0 of 5 | 1 of 30 |
| Peptic ulcer | Gastrointestinal disorders | 0 of 8 | 0 of 10 | 1 of 7 | 0 of 5 | 1 of 30 |
| Asthenia | General disorders | 0 of 8 | 0 of 10 | 1 of 7 | 0 of 5 | 1 of 30 |
| Fatigue | General disorders | 0 of 8 | 0 of 10 | 0 of 7 | 1 of 5 | 1 of 30 |
| Anorexia | Metabolism and nutrition disorders | 0 of 8 | 0 of 10 | 1 of 7 | 0 of 5 | 1 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 4 of 8 | 0 of 10 | 2 of 7 | 3 of 5 | 9 of 30 |
| Asthenia | General disorders | 3 of 8 | 2 of 10 | 2 of 7 | 2 of 5 | 9 of 30 |
| Anaemia | Blood and lymphatic system disorders | 1 of 8 | 3 of 10 | 2 of 7 | 1 of 5 | 7 of 30 |
| Nausea | Gastrointestinal disorders | 0 of 8 | 1 of 10 | 2 of 7 | 3 of 5 | 6 of 30 |
| Fatigue | General disorders | 1 of 8 | 1 of 10 | 2 of 7 | 2 of 5 | 6 of 30 |
| Leukopenia | Blood and lymphatic system disorders | 3 of 8 | 0 of 10 | 0 of 7 | 2 of 5 | 5 of 30 |
| Vomiting | Gastrointestinal disorders | 1 of 8 | 0 of 10 | 3 of 7 | 1 of 5 | 5 of 30 |
| Headache | Nervous system disorders | 1 of 8 | 0 of 10 | 2 of 7 | 2 of 5 | 5 of 30 |
| Thrombocytopenia | Blood and lymphatic system disorders | 2 of 8 | 1 of 10 | 1 of 7 | 0 of 5 | 4 of 30 |
| Diarrhoea | Gastrointestinal disorders | 0 of 8 | 1 of 10 | 1 of 7 | 2 of 5 | 4 of 30 |
Serious events with the highest arm-level rate: nausea (28.6%), vomiting (28.6%), fatigue (20.0%), anaemia (14.3%), gastric ulcer perforation (14.3%).
The registry lists serious adverse events, participants with other adverse events, and deaths by treatment group. In the sotatercept 0.1 mg/kg group, 0 of 8 participants at risk had a serious adverse event, 6 of 8 had an other adverse event, and 1 death was recorded. In the sotatercept 0.3 mg/kg group, the corresponding figures were 2 of 10, 7 of 10, and 3 deaths. In the sotatercept 0.5 mg/kg group, they were 3 of 7, 7 of 7, and 3 deaths. In the placebo group, they were 1 of 5, 5 of 5, and 0 deaths. Across the listed groups, the registry reports 6 of 30 participants with a serious adverse event, 25 of 30 with an other adverse event, and 7 deaths.
The listed serious adverse event terms and percentages include nausea and vomiting at 28.6% each, fatigue at 20.0%, and anaemia, gastric ulcer perforation, and peptic ulcer at 14.3% each. These entries describe reported events; they do not establish that an event was caused by a study intervention. The registry record does not report event relatedness, timing, or the reasons for death. Small group counts can also make percentages unstable, so the figures should be read descriptively rather than as precise comparative estimates.
12. What the Result Does, and Does Not, Mean
The study was designed to examine whether participants in each sotatercept dose regimen met a defined hematopoietic response criterion compared with participants assigned to placebo. That criterion required an increase in hemoglobin of at least 1 g/dL from baseline for 28 consecutive days, without red blood cell transfusion or erythropoiesis-stimulating agent treatment. The endpoint was intended to capture a sustained change under specified conditions, not simply a single measurement.
The registry record does not report the response percentages, confidence intervals, or primary comparison results. It therefore does not show the observed frequency of response in any group, how precise those estimates were, or whether the groups differed. The endpoint definition and study design describe what the investigators set out to assess; they are not a substitute for the results.
The record also lists safety counts, including serious adverse events, other adverse events, and deaths. These counts are a description of events recorded in the study. Without information about event timing, relatedness, follow-up, and the circumstances of each event, they cannot establish that the intervention caused or prevented an event. Nor do the listed safety counts establish a comparative safety profile.
The study was randomized, placebo-controlled, and masked, but the registry record does not report the allocation details, a full analysis plan, missing-data methods, or the reason the study was terminated. These gaps limit assessment of how the results would have been analyzed and how complete the reported evidence is. The listed enrollment was 30, and the primary analysis population had additional requirements for confirmation, treatment exposure, and time on intervention.
Accordingly, the registry record supports understanding the intended comparison, the response definition, and selected safety information. It does not support a conclusion about whether any sotatercept regimen produced a greater response than placebo, or about the magnitude and precision of such a difference. Those questions require the primary outcome results and additional analysis details, which are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why an endpoint definition and an endpoint result are different kinds of information. The registry precisely describes a sustained hemoglobin response, including its threshold, duration, and restrictions on transfusion or erythropoiesis-stimulating agent treatment. That definition helps clarify what the study intended to count. But without the arm-specific response estimates and their confidence intervals, readers cannot judge how often the outcome occurred or how much uncertainty surrounds it.
The population definition also matters statistically. The primary outcome was specified for randomized participants with confirmed chemotherapy-induced anemia who received at least one dose and remained on intervention for at least 2 months (57 days). Because this differs from enrollment alone, the analysis denominator is central to interpreting any percentage. The record does not report arm-specific denominators for the primary endpoint.
There were three active dose regimens and a placebo comparator, alongside a broad collection of outcomes and analyses. In general, multiple outcomes and comparisons require careful distinction between the primary question and secondary findings. They can also raise multiplicity concerns. The registry record does not report whether multiplicity was addressed in the analysis.
The safety information is another useful statistical lesson: counts from small groups are important to describe, but they can be imprecise and do not establish causation. The serious adverse event and death counts should be read as recorded events rather than as proof of treatment effects. Overall, the record shows the planned structure of a comparative study and some safety counts, while leaving the key efficacy estimates and several analysis details unreported.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
A major limitation for interpretation is that the primary outcome results are not reported in the registry record. There are no arm-specific response percentages or confidence intervals, and no reported primary comparison. This prevents assessment of the size, direction, and precision of the intended treatment contrast.
Enrollment was 30, and the specified primary analysis population required confirmed chemotherapy-induced anemia, at least one dose, and at least 2 months (57 days) on study intervention. The number meeting those requirements by arm is not reported. The registry record also does not report missing-data rules, treatment of participants who discontinued early, or sensitivity analyses. These details are particularly relevant for an outcome requiring a sustained change over consecutive days.
The study is listed as terminated, but the reason and any consequences for follow-up or data collection are not reported in the registry record. The record does not provide the randomization procedure, allocation concealment details, the identities of the roles covered by quadruple masking, or a complete statistical analysis plan. The stated phase and randomized, placebo-controlled design do not resolve these reporting gaps.
The registry lists 22 outcome measures and 36 analyses, but does not report whether any multiplicity adjustment was used. Safety figures are available, yet relatedness, event timing, and causes of death are not reported. The small treatment-group counts make descriptive safety comparisons uncertain, and the available information does not support causal conclusions. These limitations do not determine what the unreported results would show; they define what can be concluded from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012) — NCT00931606.
- Registry record last updated 2023-09-13; status last verified 2023-08.
- Results first posted 2023-09-13.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This terminated phase 2 study compared three subcutaneous sotatercept regimens with subcutaneous placebo in participants with chemotherapy-induced anemia and metastatic breast cancer. Each regimen was scheduled every 28 days for up to 4 doses. Enrollment was 30. The primary endpoint was the percentage achieving a sustained hemoglobin increase of at least 1 g/dL from baseline for 28 consecutive days, without transfusion or erythropoiesis-stimulating agent treatment.
The registry record does not report the primary response percentages, confidence intervals, or comparisons. It lists 22 outcome measures and 36 analyses, and reports selected adverse-event and death counts. The reason for termination, complete analysis methods, handling of missing data, and primary endpoint denominators by arm are not reported in the registry record. The available information describes the study question and some safety observations, but does not establish the comparative primary outcome results.