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 Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg (NCT02712320), a na phase 3 study. The primary outcome is Number of Participants With Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02712320 |
| Phase | Phase 3 |
| Condition | Prostatic Neoplasms |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Foresee Pharmaceuticals Co., Ltd. |
| Results posted | Yes |
2. Clinical Question
The study concerns people with advanced prostate carcinoma who had completed 12 months of treatment under Protocol FP01C-13-001 and remained eligible for continued androgen deprivation therapy. The title describes participants as having benefited from LMIS 50 mg in the earlier study. This extension followed them during additional treatment, with safety as its stated focus.
Population
Participants with advanced prostate carcinoma who had taken part in the earlier protocol, completed 12 months of treatment, and remained eligible for continued androgen deprivation therapy. The registry enrollment is 30; it does not describe the characteristics of the participants in detail.
Intervention
LMIS 50 mg, described as leuprolide mesylate administered subcutaneously. The extension regimen is described as two separate injections, at Month 12 and Month 18 from the initiation of Protocol FP01C-13-001.
Comparator
There is no comparator group. The study is open-label and single-group, so its results describe participants receiving LMIS 50 mg rather than a contrast between randomized treatment groups.
Primary question
How many participants experienced adverse events during the stated timeframe of up to 48 weeks? The primary outcome description also names drug-related adverse events and serious adverse events. The registry describes this extension as safety follow-up only.
Thus, the central statistical question is descriptive: what adverse-event experience was recorded during continued treatment in this selected group? The design does not estimate a treatment difference against a control group. It also does not answer an efficacy question. The registry record does not report a separate effectiveness comparison or an analysis of clinical benefit in the extension.
3. Trial Design
This was a Phase 3, open-label, single-group study of LMIS 50 mg, sponsored by Foresee Pharmaceuticals Co., Ltd. The registry lists an enrollment of 30 and a status of completed. The recorded start is 2016-02, and primary completion is recorded as 2017-05. The study title identifies it as an open-label safety extension for participants who had previously participated and benefited from LMIS 50 mg.
Eligibility depended on participation in Protocol FP01C-13-001, completion of 12 months of treatment under that protocol, and continued eligibility for androgen deprivation therapy. The brief description states that the extension allowed up to 12 months of additional treatment. It says participants would be followed for safety only. These features define a selected continuation group rather than a newly recruited group representative of all people with advanced prostate carcinoma.
The intervention is recorded as LMIS 50 mg. Its description specifies subcutaneous administration as two separate injections, at Month 12 and Month 18 measured from initiation of the earlier protocol. The registry lists no masking, and allocation is recorded as not applicable. There is no randomized control group or active comparator in this single-group design.
These design details determine what can be learned from the results. Adverse-event counts can describe the experience recorded during the extension, but the absence of a concurrent comparison group means they cannot isolate the effect of LMIS from other possible explanations. The registry record does not report a statistical analysis plan, an account of interim analyses, or details of a sample-size justification. The enrollment figure should not be read as proof that every enrolled participant contributed data to every outcome; outcome-specific analysis populations are not reported in the registry record.
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 | LMIS 50 mg |
|---|---|
| STARTED | 30 |
| COMPLETED | 25 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | LMIS 50 mg |
|---|---|
| Lost to Follow-up | 1 |
| Withdrawal by Subject | 1 |
| Transferred to another facility | 1 |
| Treating with the prohibited medications | 2 |
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 | LMIS 50 mg |
|---|---|---|
| Participants analysed | 30 | |
| Age, Continuous | years | 75.0 (SD 7.86) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 30 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 |
| Race (NIH/OMB): White | Participants | 25 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events, measured over Up to 48 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled “Number of Participants With Adverse Events.” It is a count endpoint: it concerns participants who experienced an event, rather than the total number of event episodes or a time-to-event measure. The stated timeframe is up to 48 weeks. Its description names the incidence of adverse events, drug-related adverse events, and serious adverse events.
Counting participants is useful in safety reporting because it conveys how many people were affected, rather than allowing repeated events in one person to be mistaken for events in separate people. This general distinction matters: a participant count and an event count answer different questions. The registry record does not provide a detailed operational definition for each adverse-event category or explain how repeated events were handled in the primary outcome.
The posted safety summary records four participants with serious adverse events and four with other adverse events in the LMIS 50 mg group. It also records zero deaths. These counts are descriptive. They do not, by themselves, provide a comparative estimate, a confidence interval, or a test of a treatment effect. The registry record does not report a separate overall count of participants with any adverse event or a drug-related adverse-event count in the posted figures.
The outcome is used to characterize safety during the extension, not to establish whether treatment caused an event. Attribution and comparison require information and design features beyond a participant count. The registry record describes safety follow-up only; it does not provide a causal analysis of the adverse events.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The LMIS 50 mg group has a recorded count of four participants with serious adverse events and four with other adverse events. The registry also records zero deaths. These figures describe the safety information posted for this single-group extension; they are not estimates of differences between treatments. The registry record does not report confidence intervals, hypothesis tests, or adjusted analyses for these counts.
The listed serious adverse-event terms are Perforated ulcer, Pyelonephritis acute, Sepsis, Hip fracture, Dyspnoea, and Knee arthroplasty. Each term is accompanied by 3.3% in the registry record. Those percentages should be read as the reported term-specific figures, not as evidence that the terms represent separate participants or non-overlapping events. The record does not provide participant-level details that would establish whether a person experienced multiple terms, nor does it report event counts for each term in the posted summary.
The enrollment is 30, and the adverse-event summary lists 30 participants at risk for both serious and other adverse events. The at-risk figures provide context for the reported counts, but a percentage or interval estimate should not be reconstructed from them. No such recalculation is needed to interpret the registry's descriptive report. In particular, the event counts do not show the precision of an estimated underlying event frequency as fully as a confidence interval would.
In general, a confidence interval expresses uncertainty around an estimate and indicates a range of values compatible with the data under the method used. No confidence interval is reported for these outcomes. Without one, and with no inferential analysis in the registry record, the results should be read as descriptive counts rather than as precise estimates of event risk.
The extension has no concurrent comparator and selects participants who had already completed treatment in an earlier protocol and remained eligible for continued therapy. Therefore, the recorded events cannot be compared with what would have occurred under another treatment or without continued treatment. The registry record also does not report baseline characteristics or participant-level follow-up details that would help assess how the enrolled group relates to other populations.
The study's safety focus is important when reading its scope: these results do not establish an efficacy finding. The posted information supports a description of the adverse-event counts and terms recorded in the extension. It does not show whether LMIS caused any particular event, whether the observed counts differ from another treatment, or how those counts would generalize beyond the selected participants.
9. Statistical Methods Explained
The registry describes the primary measure as a count of participants with adverse events. Because this is a binary participant-level outcome, each participant is classified according to whether the event category occurred during the stated timeframe. Reporting the number of participants in a category is a straightforward descriptive method. It differs from counting all event episodes, because an individual with repeated events may still contribute as one participant to a participant count.
What does a participant count tell the reader?
A count communicates the number of people recorded in an outcome category. To interpret it, readers also need to know the population at risk and the rules used to define the outcome. The posted summary gives an at-risk count of 30 for serious adverse events and 30 for other adverse events, alongside four participants in each category. These are separate category summaries; the record does not say whether the categories overlap. It is therefore not appropriate to combine them into a count of people with any adverse event.
In general, a proportion expresses a participant count relative to a specified denominator. The denominator must correspond to the outcome and analysis population, and the outcome definition must be clear. No additional proportion is calculated in this interpretation. The registry's own term-specific entries show 3.3%, and those values are retained as reported. The posted summary does not give enough detail to determine whether each term corresponds to a participant, an event episode, or a particular coding convention.
Why is the result descriptive rather than comparative?
A treatment comparison requires an outcome contrast between groups that can meaningfully represent the alternatives of interest. This study has a single group, no masking, and no comparator. Its observed counts describe what was recorded among participants receiving LMIS 50 mg during the extension. They cannot establish how the counts would differ under another treatment or under no treatment. Differences from external populations would not automatically provide a valid treatment comparison, because the groups could differ in eligibility, follow-up, outcome recording, or other characteristics.
General statistical inference can use confidence intervals to convey uncertainty in an estimate and tests to assess compatibility with a specified null hypothesis. The registry record reports no confidence intervals or hypothesis tests for the safety counts, and it lists zero analyses. Accordingly, no inferential conclusion should be attributed to these results. The absence of a reported interval is not evidence that the estimate is exact; it means the registry record does not present that precision measure.
What role does the timeframe play?
The primary outcome's stated timeframe is up to 48 weeks, while the study description refers to up to 12 months of additional treatment and follow-up for safety. These descriptions serve different purposes in the record: one specifies the outcome timeframe and the other characterizes the planned extension. The record does not provide participant-level exposure times or explain how incomplete follow-up was handled. A participant count over a specified observation window is not interchangeable with an event rate per unit of time. A time-based rate requires information about individual time at risk, which is not reported.
General safety analyses may distinguish serious from non-serious events, drug-related from events not judged related, and participants from event episodes. Those categories require definitions and adjudication or attribution rules. The registry's primary outcome description names adverse events, drug-related adverse events, and serious adverse events, but the posted figures do not provide the full set of category definitions or a separate drug-related count. The distinction between serious and other adverse events in the summary should not be assumed to resolve all of those classification questions.
Do planning assumptions describe the study design?
No. The registry's planning-illustration assumptions describe a hypothetical comparison using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They say that the effect to detect is a stated fraction of an observed effect. These are planning conventions, not evidence that the extension itself randomized participants or used a two-arm analysis. The actual design is single-group, with allocation recorded as not applicable.
In general, a sample-size calculation estimates the number of participants or events that a hypothetical design would require under specified assumptions. It is not a result observed in the trial. A calculated sample size is also not “observed power”; power is a design property conditional on assumptions, whereas observed counts are the data collected. The registry record does not report its own sample-size justification, and the hypothetical comparison assumptions should not be mistaken for the extension's protocol or analysis plan.
Over-dispersion is a general concern when variability in count data exceeds what a simple statistical model expects. A model that ignores this excess variability can understate uncertainty. That issue is not directly assessable from the posted participant counts: the record provides no fitted count model, repeated-measure structure, variance estimate, or inferential analysis. There is therefore no basis to say that an over-dispersion adjustment was used or needed in this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists five outcome measures, but the registry entries do not give the full set of outcome definitions or an analysis plan describing how they were evaluated together. It does not report a multiplicity strategy, such as a prespecified adjustment for testing multiple outcomes. With no analyses recorded and no reported hypothesis tests, there is no basis to describe a multiplicity-adjusted result or to infer that a particular outcome was selected after seeing the data.
Missing-data methods are also not reported in the registry record. The available summary does not describe withdrawals, incomplete adverse-event follow-up, missing outcome information, or any imputation or sensitivity analysis. Thus, it is not possible to assess whether the posted counts reflect complete follow-up for all enrolled participants or how missing information affected the outcome summaries.
The registry does not specify analysis populations for the primary outcome. Enrollment is recorded as 30, and the safety summary lists 30 at risk in each of its serious and other adverse-event categories, but the record does not explain the population definition or confirm that every enrolled participant contributed to every measure. No intention-to-treat, per-protocol, or safety-population definition is reported in the registry record.
These omissions limit assessment of the analysis process, but they do not change the basic description of the recorded counts. They do mean that readers cannot determine from the registry record how outcome selection, missing observations, or population rules influenced those results.
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 |
|---|---|---|---|
| LMIS 50 mg | 4 | 30 | 13.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| LMIS 50 mg | 0 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 |
|---|---|
| LMIS 50 mg | 4 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | LMIS 50 mg |
|---|---|---|
| Perforated ulcer | General disorders | 1 of 30 |
| Pyelonephritis acute | Infections and infestations | 1 of 30 |
| Sepsis | Infections and infestations | 1 of 30 |
| Hip fracture | Injury, poisoning and procedural complications | 1 of 30 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1 of 30 |
| Knee arthroplasty | Surgical and medical procedures | 1 of 30 |
| Deep vein thrombosis | Vascular disorders | 1 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | LMIS 50 mg |
|---|---|---|
| Fatigue | General disorders | 2 of 30 |
| Hypertension | Vascular disorders | 2 of 30 |
Serious events with the highest arm-level rate: perforated ulcer (3.3%), pyelonephritis acute (3.3%), sepsis (3.3%), hip fracture (3.3%), dyspnoea (3.3%).
The safety summary reports four participants with serious adverse events and four with other adverse events in the LMIS 50 mg group. It lists 30 participants at risk in each category and records zero deaths. The six serious adverse-event terms each carry a reported value of 3.3%: Perforated ulcer, Pyelonephritis acute, Sepsis, Hip fracture, Dyspnoea, and Knee arthroplasty.
These entries do not establish that each term affected a different participant. A person can experience more than one adverse event, and the registry summary does not provide the participant-level links needed to determine overlap. Nor does it state whether the term-specific percentages are based on participants, event episodes, or another reporting convention. They should be quoted as recorded rather than recombined into an overall percentage.
Seriousness is a classification of an adverse event, not by itself a statement that the treatment caused the event. The registry record does not report a separate drug-related count or a causal analysis. The figures therefore describe safety events recorded in the extension, without establishing attribution or comparative risk.
12. What the Result Does, and Does Not, Mean
The posted results mean that the registry recorded four participants with serious adverse events and four with other adverse events in the LMIS 50 mg group, alongside zero deaths. It also records six serious adverse-event terms, each reported as 3.3%. These are descriptions of the safety information entered for the extension, not estimates of the difference between treatments.
The study addresses a specific setting: an open-label continuation for participants who had completed 12 months of treatment in an earlier protocol and remained eligible for continued androgen deprivation therapy. That selected group is not interchangeable with all people with advanced prostate carcinoma. The registry record does not provide detailed participant characteristics or enough follow-up information to assess how broadly the results apply.
The results do not establish that LMIS caused the listed adverse events. A temporal record of an event during treatment is not, by itself, a causal comparison. The absence of a control group also means the posted counts cannot show whether event frequency would have been different under another treatment. No confidence intervals, hypothesis tests, or adjusted analyses are reported to quantify comparative uncertainty.
The results also do not establish an efficacy effect. The registry describes participants as having benefited in the context of the prior study, while the extension's stated purpose is safety follow-up. No efficacy comparison or treatment-effect estimate for the extension is reported in the registry record.
In general, a descriptive safety count is most useful when read alongside the event definitions, observation period, analysis population, and completeness of follow-up. Some of those details are not reported in the registry record. The available figures can therefore support a limited account of what was recorded, but not a broader conclusion about cause, comparative safety, or outcomes in populations outside the extension.
13. Why This Trial Matters Statistically
This study illustrates the statistical role of an extension study: it can document safety experience during continued treatment in a group already exposed to the treatment in an earlier protocol. Participant counts and serious-event terms make the observed safety record more concrete, while the single-group design defines the limits of interpretation.
For biostatistical reading, the distinction between a count of participants and a count of event episodes is central. The primary outcome is expressed as participants with adverse events, while the registry also supplies serious-event terms and percentages. Those data types should not be merged without definitions. In particular, term-level reports may overlap within people, and a participant count should not be treated as an event count.
The design also demonstrates why a descriptive safety result is not a causal estimate. Open-label follow-up with no comparator can show what events were recorded during the extension, but cannot determine what would have occurred under a different treatment. A selected group of prior participants further narrows the population to which the observations directly apply.
Finally, the record shows the value of reporting analysis details alongside counts. Definitions, analysis populations, missing-data handling, confidence intervals, and an analysis plan would help readers judge completeness and precision. Since those details are not reported in the registry record, the appropriate statistical interpretation remains focused on the posted descriptive results and their limits.
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 main trial-specific limitation is the single-group design. With no comparator and no random allocation, the adverse-event counts cannot estimate a treatment contrast. Open-label follow-up can also affect how symptoms are noticed, reported, or classified; the registry record does not describe procedures intended to address that possibility.
The participants were selected from an earlier study: they had completed 12 months of treatment and remained eligible for continued androgen deprivation therapy. The results therefore describe a continuation group, not an unselected population with advanced prostate carcinoma. Participant characteristics beyond the condition and prior-study eligibility are not reported in the registry record.
The record does not provide participant-level follow-up, withdrawals, event timing, or the handling of incomplete observation. Although the extension description states up to 12 months of additional treatment and the primary outcome timeframe is up to 48 weeks, the relationship between those periods and each participant's observed time is not detailed. Event rates over person-time cannot be assessed from the available summary.
The safety summary does not explain the term-specific percentage calculation or whether terms overlap in the same participants. The posted figures also do not include a separate count for all participants with any adverse event or a drug-related adverse-event count. No confidence intervals, hypothesis tests, adjusted analyses, or analysis-population definitions are reported. These limitations restrict both precision assessment and causal interpretation.
The registry record does not report a sample-size justification, missing-data strategy, or multiplicity plan. These omissions do not invalidate the descriptive counts, but they prevent a fuller assessment of how the study was designed and how complete or robust its analyses were.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg — NCT02712320.
- Registry record last updated 2019-03-26; status last verified 2019-02.
- Results first posted 2018-09-12.
- 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
NCT02712320 is a completed Phase 3, open-label, single-group safety extension of LMIS 50 mg in participants with advanced prostate carcinoma who had previously participated in Protocol FP01C-13-001. The study allowed up to 12 months of additional treatment and was intended for safety follow-up. The recorded enrollment is 30; the study start is 2016-02 and primary completion is 2017-05.
The primary outcome is the number of participants with adverse events, with a stated timeframe of up to 48 weeks. The safety summary records four participants with serious adverse events, four with other adverse events, and zero deaths. Six serious-event terms are each reported as 3.3%. The study has no comparator, and the registry record reports no statistical analyses, confidence intervals, hypothesis tests, analysis-population definitions, or missing-data methods. The findings are descriptive and do not establish causation or comparative treatment effects.