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 Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta® (NCT01735175), a randomized phase 3 study. The primary outcome is Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01735175 |
| Phase | Phase 3 |
| Condition | Neutropenic Complications, Breast Neoplasms, Chemotherapy-induced Neutropenia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 316 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sandoz |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned breast cancer patients treated with myelosuppressive chemotherapy. The registry identifies the analysis populations as the full analysis set (FAS) and the per protocol set (PP), but does not report their detailed eligibility or membership rules in the record. It therefore does not establish, from these labels alone, which patients contributed to each particular analysis.
Intervention
Patients assigned to LA-EP2006 received it by subcutaneous application after chemotherapy during each chemotherapy cycle. The registry describes the study as randomized and quadruple masked; its official title also calls it double-blind. The record does not explain the masking arrangements or identify which groups of people were masked.
Comparator
The comparator was Neulasta®, administered by subcutaneous application after chemotherapy during each chemotherapy cycle. The comparison was parallel-group, so the record describes patients assigned to one treatment group or the other rather than a crossover design. The registry does not report the detailed assignment procedure.
Primary question
The primary endpoint was mean duration of severe neutropenia during cycle one of chemotherapy, with a timeframe of 21 days. Severe neutropenia was defined as consecutive days with ANC <0.5 × 10^9 cells/L, corresponding to grade 4 neutropenia. The clinical question was whether this mean duration differed between the treatment groups. A single numerical comparison, its uncertainty, and a test result are not reported in the registry record.
3. Trial Design
The registry describes a randomized, parallel-group, multicenter Phase III comparative study of LA-EP2006 and Neulasta® in breast cancer patients receiving myelosuppressive chemotherapy. The trial status is completed, and the recorded enrollment is 316. The study start is listed as 2012-06 and primary completion as 2013-05. These dates describe the registry record; they do not by themselves specify the follow-up duration for each participant.
Both groups received their assigned study drug by subcutaneous application after chemotherapy during each chemotherapy cycle. The official title describes the trial as double-blind, while the registry masking field specifies quadruple masking. The record does not explain how masking was implemented, who was masked, or whether the two descriptions refer to different aspects of the study. It is not possible to infer those details from the labels alone.
The primary endpoint concerned mean duration of severe neutropenia during cycle one, within a 21-day timeframe. The registry also lists outcomes related to febrile neutropenia, fever, ANC nadir, ANC recovery, infections, and mortality due to infection. Their descriptions identify several cycle-specific and across-cycle measures. The record lists 8 outcome measures and 2 analyses, but does not give a complete statistical analysis plan or enough information to reconstruct the analysis attached to each measure.
The registry identifies FAS and PP analysis populations. It does not report the detailed rules for inclusion in either set, the number analyzed for the primary endpoint, or how participants with missing measurements were handled. It also does not report a single primary contrast or a numerical primary result. Although the study is described as comparative, its design labels alone do not establish the size or precision of any treatment difference.
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 | LA-EP2006 | Neulasta® |
|---|---|---|
| STARTED | 159 | 157 |
| Completed All Cycles | 141 | 150 |
| Completed All Treatments as Planned | 140 | 150 |
| Completed the 6-month SFU Visit | 120 | 138 |
| COMPLETED | 130 | 144 |
| NOT COMPLETED | 29 | 13 |
Reasons for not completing this period:
| Reason | LA-EP2006 | Neulasta® |
|---|---|---|
| Withdrawal by Subject | 9 | 2 |
| Lost to Follow-up | 4 | 2 |
| Death | 3 | 2 |
| Other (mostly EOS/EOT visit missing) | 13 | 7 |
Analysis population for the primary outcome, as defined in the registry: FAS set = full analysis set; PP set = per protocol set
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 | LA-EP2006 | Neulasta® | Total |
|---|---|---|---|---|
| Participants analysed | 159 | 157 | 316 | |
| Age, Continuous | years | 49.9 (SD 9.53) | 50.5 (SD 10.87) | 50.2 (SD 10.20) |
| Sex: Female, Male: Female | Participants | 159 | 157 | 316 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 11 | 18 | 29 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 148 | 139 | 287 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 28 | 26 | 54 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 129 | 127 | 256 |
| Race (NIH/OMB): More than one race | Participants | 2 | 4 | 6 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| BMI | kg/m^2 | 27.47 (SD 26.76) | 27.44 (SD 26.35) | 27.45 (SD 26.40) |
| Time since diagnosis | months | 1.35 (0.1 to 76.0) | 1.38 (0.2 to 10.9) | 1.38 (0.1 to 76.0) |
| Disease stage: I | Participants | 4 | 3 | 7 |
| Disease stage: II | Participants | 74 | 73 | 147 |
| Disease stage: III | Participants | 81 | 78 | 159 |
| Disease stage: IV | Participants | 0 | 3 | 3 |
| Previous breast cancer surgery | Participants | 149 | 146 | 295 |
| Previous radiotherapy | Participants | 7 | 9 | 16 |
| ECOG performance status: 0 (fully active) | Participants | 128 | 123 | 251 |
| ECOG performance status: 1 (restricted in physically strenuous activity) | Participants | 31 | 34 | 65 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy, measured over 21 days (Cycle 1 of chemotherapy treatment).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | days |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was mean duration of severe neutropenia during cycle one of chemotherapy. Duration was measured in days within a timeframe of 21 days. Severe neutropenia was defined as the number of consecutive days with ANC <0.5 × 10^9 cells/L, described as grade 4 neutropenia. This definition makes the endpoint a continuous measure of duration rather than a simple indicator of whether severe neutropenia occurred at any time.
In general, a duration measure can convey how long a clinically defined state persisted, while an occurrence measure answers whether it happened. A group mean summarizes the average duration across the people included in an analysis. It does not, by itself, describe the distribution: patients may have similar durations or widely varying durations even when the mean is the same. The standard deviation is the registry’s stated measure of dispersion, intended to describe variation among observed durations.
Cycle one provides a defined period for the primary assessment, but the registry does not report how daily ANC measurements were collected, how a qualifying run of consecutive days was handled when observations were missing, or how the endpoint was calculated for participants without an observed qualifying episode. Those details matter because a duration derived from repeated measurements depends on both the measurement schedule and the rules used to define the start and end of an episode.
The endpoint is useful for comparing the average time spent in severe neutropenia between treatment groups, but it is not interchangeable with the incidence of febrile neutropenia, infection, or other clinical outcomes. Those are listed separately as secondary outcomes. The registry record does not report the group means, their contrast, a confidence interval, or a p-value for the primary endpoint. Consequently, the endpoint’s definition can be described, but its observed comparison cannot be quantified from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies the research question and the primary outcome definition, but it does not report a single numerical comparison for mean duration of severe neutropenia. Group-specific means, the difference between means, an interval estimate, and a hypothesis-test result are not reported in the registry record. Without those results, the magnitude and precision of the primary comparison cannot be assessed. The trial design and endpoint definition do not substitute for an estimate of the outcome.
In general, a difference in group means describes the average separation between the groups on a continuous outcome. A confidence interval communicates the range of values compatible with the data under the statistical model and gives information about precision. A narrow interval indicates greater precision than a wide interval, while an interval spanning values on either side of no difference may leave the direction and size of the underlying effect uncertain. These are general interpretations; no confidence interval for the primary endpoint is reported in the registry record.
The registry states that the endpoint is a mean and that its dispersion is measured by the standard deviation. A standard deviation describes the spread of individual observed values around the group mean; it is not the same as a confidence interval for that mean or for a between-group contrast. The record does not provide the endpoint’s group-level standard deviations or a complete result from which such uncertainty could be evaluated.
There are secondary outcomes addressing febrile neutropenia, fever, ANC nadir, ANC recovery, infections, and mortality due to infection. Their presence indicates that the study recorded outcomes beyond the primary duration measure, but does not establish what those outcomes showed. Numerical results for these measures are not reported in the registry record, so they cannot be used to fill the gap in the primary result or to make claims about comparative clinical effects.
The serious adverse event record includes group-level counts of participants at risk and affected, and lists serious-event terms with percentages. These safety data should be read separately from efficacy outcomes. They do not provide a complete account of event timing, severity patterns, causal attribution, or statistical uncertainty. In particular, the recorded death counts do not identify causes in the adverse-event summary, even though mortality due to infection is listed as a secondary outcome.
The registry describes the study as randomized, which is relevant to the intended comparison, but a design label does not resolve questions about analysis populations, missing outcome data, or the handling of multiple outcomes. Those methods are not reported in sufficient detail to evaluate their possible effect on the primary estimate. The appropriate interpretation is therefore limited: the study was designed to compare the treatments on a defined cycle-one duration measure, while the registry record does not provide the numerical primary comparison needed to judge its size or precision.
9. Statistical Methods Explained
What does the primary measure summarize?
The endpoint is a mean of a continuous measure: duration in days. Each participant’s value represents consecutive days meeting the registry definition of severe neutropenia during cycle one. The group mean then summarizes the observed durations for the participants included in that analysis. A mean is expressed in the same units as the measured variable, so this endpoint is interpreted in days rather than as a percentage or event count.
In general, a mean is sensitive to unusually large or small observations. The distribution of individual durations can therefore be important, especially if many observations cluster at one value while a smaller number extend farther away. A standard deviation describes the spread of individual values around the mean. It does not tell the reader whether the distribution is symmetric, whether there are influential observations, or how precisely the mean difference is estimated. The registry does not report the distributions or endpoint summaries needed to assess those features.
How would a treatment comparison be interpreted?
For a continuous endpoint, an analysis may compare group means directly or use a model that adjusts for other recorded variables. In general, an unadjusted comparison describes the difference between the observed group means without covariate adjustment. An adjusted analysis estimates a comparison conditional on the variables included in its model. The registry record does not report which method was used for the primary endpoint, what covariates may have been included, or a numerical estimate from either approach. No particular analysis method should therefore be attributed to this trial.
A confidence interval is a way to express uncertainty around an estimate. In general, it combines information about the estimated contrast and its sampling variability. It helps distinguish a precise estimate from one that remains compatible with a broad range of possible effects. A p-value, when reported, addresses how incompatible the observed data are with a specified null hypothesis under the chosen model; it does not measure clinical importance or the probability that a treatment is effective. Neither an interval nor a p-value for the primary comparison is reported in the registry record.
Why does the endpoint definition matter?
The endpoint requires consecutive days below the ANC threshold, rather than simply recording any low measurement. In general, rules for consecutive observations can make the outcome sensitive to the frequency and timing of assessments. Missing measurements may interrupt or obscure an observed sequence, and decisions about whether to count a gap can affect the derived duration. The registry record does not describe the measurement schedule or rules for handling gaps, so these details cannot be evaluated.
The timeframe is 21 days during cycle one. Restricting the primary measure to a defined cycle provides a common assessment window, but it does not answer questions about later cycles or longer-term outcomes. The registry lists several outcomes assessed by cycle and across all cycles, but does not provide their numerical results. The primary endpoint should therefore be understood as a cycle-specific measure rather than a summary of all later treatment periods.
What role do planning assumptions play?
The registry’s sample-size assumptions describe planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. These are planning scenarios, not evidence about the result of a new comparison. A calculated sample size under such assumptions is not observed power, and it cannot show that the completed study had a particular probability of detecting an effect.
In general, planning calculations depend on the assumed effect, variability, allocation, significance level, and analysis method. Changing an assumption can change the resulting target. Since the registry does not report the observed primary effect or all details needed to assess the calculations, the planning illustrations cannot be independently evaluated from the registry record. The sample-size rationale used when the trial was designed is not reported in the registry record.
Could count outcomes use different methods?
Some secondary outcomes concern occurrences or numbers of events rather than a mean duration. In general, binary outcomes such as whether a participant experienced an event can be summarized with group proportions and compared using an appropriate model. Recurrent event counts may require methods that account for the amount of observation time and for variation greater than expected under a simple count model. Over-dispersion, in general, means that event counts vary more than the model assumes; ignoring it can make uncertainty estimates too small. The registry record does not specify the models used for the listed secondary outcomes, so these are methodological considerations rather than descriptions of analyses conducted in this trial.
The record lists 2 analyses but does not explain their relationship to the endpoint populations, state whether either was primary, or give the corresponding numerical estimates. The statistical method, analysis set, and result must be considered together to understand a comparison. With those details not reported, the design and definitions support a description of the intended question, but not an independent reconstruction of the statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and several secondary outcomes, including measures of febrile neutropenia, fever, ANC nadir, ANC recovery, infections, and mortality due to infection. It also records 8 outcome measures and 2 analyses. The statistical plan for controlling the chance of false-positive findings across multiple outcomes or analyses is not reported in the registry record. No testing hierarchy, adjustment method, or distinction between confirmatory and exploratory analyses is described. General caution is appropriate when interpreting numerous outcome tests, because repeated testing can increase the chance of at least one apparently notable result.
The record identifies FAS as the full analysis set and PP as the per protocol set. Those labels do not, by themselves, specify who was included, how protocol deviations were handled, or which set was used for the primary endpoint. The detailed analysis-population definitions and the numbers analyzed in each set are not reported in the registry record. It is therefore not possible to determine whether results were intended to be interpreted primarily under one population definition or how any differences between analyses were addressed.
Missing-data methods are also not reported in the registry record. The record does not describe how missing ANC observations, incomplete follow-up, or missing endpoint values were handled, whether any imputation was used, or how sensitivity to those decisions was assessed. For a duration endpoint based on consecutive measurements, missing observations could affect how an episode is identified; this is a general methodological concern, not evidence that a particular amount of data was missing in this trial.
The primary numerical result, analysis method, multiplicity approach, and missing-data approach are not reported. Without those details, readers cannot evaluate the robustness of a primary comparison or distinguish a planned confirmatory analysis from additional analyses.
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 |
|---|---|---|---|
| LA-EP2006 | 16 | 159 | 10.1% |
| Neulasta® | 21 | 157 | 13.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| LA-EP2006 | 4 of 159 |
| Neulasta® | 2 of 157 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| LA-EP2006 | 140 of 159 |
| Neulasta® | 128 of 157 |
Most frequent serious adverse event terms
| Event term | Organ system | LA-EP2006 | Neulasta® |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 9 of 159 | 12 of 157 |
| Neutropenia | Blood and lymphatic system disorders | 3 of 159 | 6 of 157 |
| Anemia | Blood and lymphatic system disorders | 1 of 159 | 2 of 157 |
| Neutropenic sepsis | Infections and infestations | 2 of 159 | 0 of 157 |
| Pyrexia | General disorders | 1 of 159 | 1 of 157 |
| Cardio-respiratory arrest | Cardiac disorders | 2 of 159 | 0 of 157 |
| Leukopenia | Blood and lymphatic system disorders | 0 of 159 | 1 of 157 |
| Pancytopenia | Blood and lymphatic system disorders | 0 of 159 | 1 of 157 |
| Thrombocytopenia | Blood and lymphatic system disorders | 0 of 159 | 1 of 157 |
| Cellulitis | Infections and infestations | 1 of 159 | 0 of 157 |
Most frequent non-serious adverse event terms
| Event term | Organ system | LA-EP2006 | Neulasta® |
|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | 82 of 159 | 79 of 157 |
| Nausea | Gastrointestinal disorders | 64 of 159 | 58 of 157 |
| Asthenia | General disorders | 63 of 159 | 56 of 157 |
| Vomitting | Gastrointestinal disorders | 34 of 159 | 32 of 157 |
| Neutropenia | Blood and lymphatic system disorders | 25 of 159 | 30 of 157 |
| Diarrhoe | Gastrointestinal disorders | 23 of 159 | 31 of 157 |
| Fatigue | General disorders | 18 of 159 | 21 of 157 |
| Anemia | Blood and lymphatic system disorders | 16 of 159 | 17 of 157 |
| Erythema | Skin and subcutaneous tissue disorders | 14 of 159 | 16 of 157 |
| Leukopenia | Blood and lymphatic system disorders | 11 of 159 | 12 of 157 |
Serious events with the highest arm-level rate: febrile neutropenia (7.6%), neutropenia (3.8%), anemia (1.3%), neutropenic sepsis (1.3%), cardio-respiratory arrest (1.3%).
The registry reports serious adverse event information separately for the two treatment groups. For LA-EP2006, 159 participants were listed as at risk and 16 as affected. For Neulasta®, 157 were listed as at risk and 21 as affected. These are the registry’s group-level counts; they should not be converted into comparative rates without ensuring that the definitions, observation periods, and denominators are appropriate and consistent.
The record also lists serious-event terms with percentages: febrile neutropenia, 7.6%; neutropenia, 3.8%; anemia, 1.3%; neutropenic sepsis, 1.3%; cardio-respiratory arrest, 1.3%; and leukopenia, 0.6%. The listed percentages do not, in the record described, establish the denominator or provide a group-specific breakdown for each term. They should not be treated as a complete event profile or as directly comparable percentages between groups.
Deaths are recorded as 4 for LA-EP2006 and 2 for Neulasta®. The adverse-event summary does not state that these deaths were due to infection, nor does it give cause-specific details. Mortality due to infection is listed separately as a secondary outcome, but its numerical result is not reported in the registry record. These safety summaries do not establish causation, comparative risk, or statistical significance; event timing and further clinical context are not reported.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this completed randomized Phase III study compared LA-EP2006 with Neulasta® in breast cancer patients receiving myelosuppressive chemotherapy. It identifies a specific primary outcome: mean duration of severe neutropenia during cycle one, measured over 21 days and defined using consecutive days with ANC <0.5 × 10^9 cells/L. It also identifies other outcomes and provides a limited serious adverse event summary.
What the record does not establish is the numerical primary treatment comparison. Group means, a contrast, a confidence interval, and a p-value are not reported in the registry record. Without those values, it is not possible to describe the direction, magnitude, or precision of the primary result. The fact that a comparative trial was conducted does not itself show whether the groups had similar or different outcomes.
In general, statistical interpretation distinguishes an estimate from its uncertainty and from its clinical relevance. An estimate describes the observed comparison; an interval describes its precision under the analysis; clinical relevance requires context beyond whether a statistical test crosses a threshold. Because the primary estimate and its uncertainty are not reported, none of those aspects can be assessed for the primary endpoint from this record.
The listed secondary outcomes and adverse event counts also have limits. Outcome names show what the registry intended to assess, not what the assessments found. Serious-event counts and terms provide descriptive information, but the available record does not provide full event-level context, causal attribution, or a statistical comparison. The death counts do not identify cause, and cannot be equated with the separately listed mortality-due-to-infection outcome.
Accordingly, the defensible conclusion is about the study question and reporting, not treatment effects: the trial was designed to compare the products on a defined neutropenia-duration measure, but the registry record does not report a single numerical primary result that would support a conclusion about the observed comparison. The record also does not provide enough detail to assess the analysis populations, missing-data handling, multiplicity control, or model choice.
13. Why This Trial Matters Statistically
This study is statistically notable as a randomized, parallel-group Phase III comparison built around a continuous clinical measure: mean duration of severe neutropenia. That endpoint differs from an event indicator. It asks about the length of a qualifying period, rather than only whether a qualifying event occurred. This distinction matters because measures of occurrence and duration capture different aspects of a clinical course and should not be treated as interchangeable.
The endpoint also depends on a threshold and a consecutive-day rule. In general, this makes operational details important: the observation schedule, handling of gaps, and method for deriving duration can influence the value analyzed. The registry defines the ANC threshold and the cycle-one timeframe, but does not report those data-collection and derivation details. This illustrates why endpoint definitions and analysis procedures are both needed to interpret a result.
Another statistical issue is that the registry lists several secondary measures across cycles, alongside the primary endpoint. Multiple outcomes can offer a broader account of what was measured, but they also create questions about which comparisons were planned as confirmatory, how multiplicity was handled, and how missing data were treated. Those methods are not reported in the registry record. The existence of multiple outcomes does not establish that any result was positive or reliable.
Finally, the record shows the difference between a trial’s design and its reported evidence. Randomization and masking are design features; they do not convey an effect estimate or its precision. Here, the primary outcome is defined, but its numerical comparison is not reported. For statistical readers, that distinction is central: a clear question and design do not make an unreported result interpretable, and incomplete methods limit evaluation of even a reported estimate.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting this trial from the registry record is the absence of a single numerical primary comparison. The record does not report group means, the between-group estimate, its confidence interval, or a p-value for mean duration of severe neutropenia. It also does not give the standard deviations for the primary endpoint. The magnitude and precision of the primary result therefore cannot be assessed.
The registry indicates that the primary outcome has several categories or time points and is not reduced to one comparison. As a result, the record does not supply a single primary result suitable for a straightforward treatment-group interpretation. The detailed reason for the multiple categories or time points and the analysis plan connecting them are not reported in the registry record.
Important analysis details are also absent. The record names FAS and PP populations but does not report their detailed definitions, the population used for each endpoint, or the number analyzed for the primary outcome. Missing-data procedures, endpoint derivation when measurements are incomplete, the primary statistical model, and sensitivity analyses are not reported in the registry record. The multiplicity strategy for the listed outcomes and analyses is likewise not reported.
Safety reporting is limited to group-level at-risk and affected counts, a list of serious-event terms with percentages, and death counts. The record does not provide event timing, complete group-specific term counts, causes for the deaths, or enough context to interpret the listed percentages as comparative risks. These limitations concern the available registry record and should not be taken as proof that further information does not exist elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta® — NCT01735175.
- Registry record last updated 2017-08-07; status last verified 2017-06.
- Results first posted 2017-06-15.
- 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
NCT01735175 is a completed randomized, quadruple-masked, parallel-group Phase III study sponsored by Sandoz. Its official title describes a double-blind, multicenter comparison of LA-EP2006 and Neulasta® in breast cancer patients receiving myelosuppressive chemotherapy. Enrollment is recorded as 316; the study start is 2012-06 and primary completion is 2013-05.
The primary endpoint was mean duration of severe neutropenia in cycle one, within 21 days. Severe neutropenia was defined as consecutive days with ANC <0.5 × 10^9 cells/L. Secondary outcomes included febrile neutropenia, fever, ANC nadir and recovery, infections, and mortality due to infection. FAS and PP analysis populations are named, but their detailed rules are not reported.
A single numerical primary comparison, including its estimate and uncertainty, is not reported in the registry record. The statistical analysis plan, multiplicity approach, and missing-data methods are also not reported. The adverse-event record gives group-level affected counts, serious-event terms with percentages, and death counts, but does not provide sufficient context for a complete comparative safety interpretation.