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 A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants (NCT02993926), a registered phase not stated study. The primary outcome is Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02993926 |
| Phase | Phase not stated |
| Condition | Central Precocious Puberty |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 108 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Takeda |
| Results posted | Yes |
2. Clinical Question
The registry record concerns Chinese participants with central precocious puberty (CPP) who received Enantone. It describes a retrospective observational study of treatment safety and effectiveness, rather than a randomized comparison. The treatment-phase group included participants treated with Enantone for at least 9 continuous months; the record also describes follow-up groups based on whether participants stopped CPP treatment or continued with a non-Enantone gonadotropin releasing hormone agonist (GnRHa).
Population
Participants with CPP in China. The enrolled population was 108 participants, and the safety analysis set included all enrolled participants.
Intervention
Enantone (leuprorelin), described in the treatment phase at doses from ≥ 30 μg/kg up to 180 μg/kg. The record gives a mean treatment exposure of 22.3 months.
Comparator
There was no randomized, like-for-like control comparison. Follow-up descriptions distinguish participants no longer treated for CPP from those treated with a non-Enantone GnRHa after Enantone.
Primary question
How many participants experienced at least one treatment-emergent adverse event (TEAE) and how many experienced a serious adverse event (SAE) during Enantone treatment and through the specified post-treatment period?
The record also lists hormone suppression and bone-age outcomes at the ends of treatment and follow-up. Those outcomes address aspects of treatment effectiveness, but their numerical results are not reported in the registry record. The central interpretive question is therefore what the posted safety counts can describe, and what cannot be established without outcome estimates, an appropriate comparison group, and details of the analysis.
3. Trial Design
This is described as an observational, retrospective study. The registry record lists 108 enrolled participants and a completed status. The study start date is 2017-06-24, and the primary completion date is 2018-09-30. The stated purpose was to evaluate the long-term safety and effectiveness of Enantone for CPP in Chinese participants.
The treatment-phase description includes participants who received Enantone for at least 9 continuous months and initiated and received their last treatment dose during the index period from 01 September 1998 to 30 September 2018. The stated dose range is ≥ 30 μg/kg up to 180 μg/kg. Mean Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months. These eligibility and exposure details describe the treatment group; they do not establish that all participants had identical treatment histories.
Two follow-up groups are described. One comprises participants who completed CPP treatment during the Enantone treatment phase and were no longer on treatment. Their mean follow-up was 8.75 months, with a range of 1.9 to 29.5 months. The other comprises participants continuing CPP treatment with a non-Enantone GnRHa after Enantone. Their mean follow-up while on another GnRHa was 10.80 months, with a range of 2.8 to 20.5 months.
Allocation is not stated, and the registry record does not describe a randomized comparison. The follow-up groups are therefore not like-for-like control arms: their treatment status and follow-up circumstances differ by definition. The record lists Enantone and GnRH agonist interventions, but does not report a protocol for assigning participants to those treatment histories. It also does not report enough information to determine how participant selection, records, or follow-up were handled beyond the descriptions above.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Participants with a diagnosis of central precocious puberty (CPP) who previously received Enantone for at least 9 continuous months in clinical practice index period: 1 September 1998 to 30 September 2018 were enrolled in this study.
Enantone Treatment Phase
| Stage | Treatment Phase: Enantone | Follow Up: Participants No Longer Treated for CPP | Follow Up: Treated With Non-Enantone GnRHa After Enantone |
|---|---|---|---|
| STARTED | 108 | 0 | 0 |
| COMPLETED | 76 | 0 | 0 |
| NOT COMPLETED | 32 | 0 | 0 |
Reasons for not completing this period:
| Reason | Treatment Phase: Enantone | Follow Up: Participants No Longer Treated for CPP | Follow Up: Treated With Non-Enantone GnRHa After Enantone |
|---|---|---|---|
| Adverse Event | 1 | 0 | 0 |
| Changed CPP Therapy to Another GnRHa | 26 | 0 | 0 |
| Investigator Judgment | 1 | 0 | 0 |
| Reason Not Specified | 4 | 0 | 0 |
Follow-Up Phase
| Stage | Treatment Phase: Enantone | Follow Up: Participants No Longer Treated for CPP | Follow Up: Treated With Non-Enantone GnRHa After Enantone |
|---|---|---|---|
| STARTED | 0 | 44 | 26 |
| COMPLETED | 0 | 44 | 26 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety Analysis Set included all enrolled participants. Data in this outcome measure is reported separately for male and female participants.
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.
Population: Safety Analysis Set included all enrolled participants.
| Characteristic | Unit | Treatment Phase: Enantone |
|---|---|---|
| Participants analysed | 108 | |
| Age, Continuous | years | 8.45 (SD 1.124) |
| Sex: Female, Male: Female | Participants | 104 |
| Sex: Female, Male: Male | Participants | 4 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: China | Participants | 108 |
| Tanner Staging Evaluation: Breast (Female) and Genitals (Male), Stage I | Participants | 1 |
| Tanner Staging Evaluation: Breast (Female) and Genitals (Male), Stage II | Participants | 49 |
| Tanner Staging Evaluation: Breast (Female) and Genitals (Male), Stage III | Participants | 46 |
| Tanner Staging Evaluation: Breast (Female) and Genitals (Male), Stage IV | Participants | 3 |
| Tanner Staging Evaluation: Pubic Hair, Stage I | Participants | 75 |
| Tanner Staging Evaluation: Pubic Hair, Stage II | Participants | 14 |
| Peak Stimulated Luteinizing Hormone (LH) | U/L | 16.935 (SD 10.7717) |
| Peak Stimulated Follicle Stimulating Hormone (FSH) | U/L | 14.407 (SD 5.9366) |
| Estradiol | ng/L | 23.3453 (SD 18.1633) |
| Testosterone | pg/mL | 70.4653 (SD 127.7357) |
| Bone Age/Chronological Age Ratio | ratio | 1.22 (SD 0.122) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase, measured over During treatment with and up to 30 days post last dose of Enantone (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary safety outcome counts participants with at least one treatment-emergent adverse event (TEAE) and serious adverse event (SAE) during the Enantone treatment phase. Its timeframe includes treatment and up to 30 days after the last Enantone dose. The stated mean Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months.
A TEAE is defined in the registry record as an untoward medical occurrence in a participant administered a medicinal product; it does not necessarily have to be causally related to that treatment. An SAE is an adverse event resulting in death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability or incapacity, or congenital anomaly, or deemed significant for another reason.
Counting participants rather than individual event episodes gives a straightforward measure of how many people had at least one event in the specified period. The serious-event count separates events meeting the record’s seriousness definition from other reported events. These counts are useful for describing observed safety experience, but they do not by themselves establish that treatment caused an event or quantify a participant’s risk relative to an untreated or otherwise comparable group.
The safety analysis set included all enrolled participants. The registry states that the primary outcome is reported separately for male and female participants, but sex-specific numerical results are not reported in the record. The listed outcome title refers to participants with at least one TEAE and SAE; posted group-level safety figures distinguish serious events from other adverse events.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the Enantone treatment phase, the posted figures report 2 participants with serious adverse events among 108 at risk, 63 with other adverse events among 108 at risk, and 0 deaths. These are descriptive counts for the recorded treatment phase and its specified post-dose window. They should not be interpreted as a causal estimate of the effect of Enantone: the study is observational, allocation is not stated, and no randomized comparison is described.
For follow-up among participants no longer treated for CPP, 0 of 44 participants at risk were reported with a serious adverse event, 0 of 44 with another adverse event, and 0 deaths. Among participants treated with a non-Enantone GnRHa after Enantone, 0 of 26 were reported with a serious adverse event, 9 of 26 with another adverse event, and 0 deaths. These follow-up groups differ in treatment status and are not a like-for-like control comparison. Their counts should not be read as evidence that one follow-up condition is safer than another.
The registry lists Pneumonia and Hair follicle tumour benign among the top serious-event terms, each at 0.9%. Event terms describe recorded events, not proof of treatment causation. The record’s TEAE definition explicitly does not require a causal relationship. A count of affected participants also does not show how many event episodes occurred, how long events lasted, or how severe non-serious events were.
The observed counts are not accompanied in the record by confidence intervals, p-values, adjusted estimates, or a statistical analysis plan. The precision of a count cannot be fully assessed from the count alone; in general, a confidence interval describes uncertainty around an estimate, but no such interval is reported. The registry lists 10 outcome measures, while numerical results for the listed hormone and bone-age outcomes are not reported in the registry record. Thus the posted safety counts do not answer the study’s effectiveness questions.
Exposure and follow-up durations varied. In general, when participants contribute different amounts of observation time, simple counts do not account for those differences in time at risk. The record gives mean durations and ranges for the treatment and follow-up groups, but does not report time-adjusted event rates. The counts are best read as a description of the events recorded in the stated groups and periods, not as comparative risks or a complete account of long-term safety.
9. Statistical Methods Explained
The registry record describes an observational, retrospective study and does not report a statistical analysis plan. The methods discussion below explains general statistical considerations relevant to the posted counts; it does not imply that the study used particular inferential procedures.
What do participant counts represent?
A count of participants with an event records whether each participant experienced at least one event during the specified period. This differs from counting total event episodes: one participant may experience more than one event, but the primary outcome is framed as the number of participants with at least one TEAE and SAE. Counts are easy to interpret as observed data, but their meaning depends on the population included, the time window, and how events were ascertained.
The Enantone safety outcome is framed for the treatment phase and up to 30 days after the last dose. The record defines TEAEs as medical occurrences after administration that need not be caused by treatment, and defines SAEs by specified serious consequences or other significance. These definitions establish which events belong in each category; they do not establish attribution.
Why distinguish descriptive results from comparisons?
In general, a comparison of treatments requires groups that can support a meaningful contrast. Random allocation can help balance measured and unmeasured participant characteristics, while observational groups may differ for reasons related to treatment history, clinical circumstances, or follow-up. The registry record states that allocation is not stated and that the arms are not a like-for-like control comparison. Consequently, the posted counts are descriptive and do not isolate a treatment effect.
The follow-up categories are defined by what happened after Enantone: some participants were no longer treated for CPP, while others continued with a non-Enantone GnRHa. Their treatment circumstances are different by construction. A numerical difference between such groups, even if one were calculated, would not alone demonstrate that the treatment choice caused the difference. No such derived comparison is reported.
What would uncertainty estimates add?
In general, a confidence interval expresses the range of values reasonably compatible with an estimate under a specified statistical model and sampling assumptions. It helps readers judge precision, rather than treating a point estimate as exact. The registry record does not report confidence intervals for these event counts. It also does not report p-values or adjusted estimates. Therefore, the posted figures do not support claims of statistical significance or a quantified comparative effect.
When an outcome is uncommon, estimates can be particularly imprecise, and zero observed events in a group does not prove that the underlying event probability is zero. This is a general statistical point, not a conclusion that the record supplies an estimate of an underlying probability. The follow-up groups have different numbers at risk, and their zero serious-event counts are observations in those groups rather than proof of absence of risk.
Why does time at risk matter?
A simple participant count does not account for how long each participant was observed. In general, rates that use person-time can be useful when observation durations differ, provided the data and assumptions support such an analysis. The record reports a mean Enantone exposure of 22.3 months, ranging from 10.1 to 52.4 months. It reports mean follow-up of 8.75 months for participants no longer treated, with a range of 1.9 to 29.5 months, and mean follow-up of 10.80 months for participants on another GnRHa, with a range of 2.8 to 20.5 months. It does not report time-adjusted event rates or the analysis methods needed to evaluate such rates.
Follow-up length can affect the opportunity to record an event. Thus group counts should be interpreted in light of the stated observation periods, and not as directly comparable rates. The registry record does not describe whether or how censoring, incomplete follow-up, or differences in observation time were addressed analytically.
What does the planning illustration mean?
In general, a sample-size planning illustration asks how many participants might be needed under stated assumptions to detect a chosen effect with a chosen statistical procedure. Such a calculation is prospective planning, not evidence about the observed study’s power. The stated assumptions for the illustration include a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For non-time-to-event outcomes, results are expressed as participants per arm for 80% or 90% power; time-to-event illustrations use a total event count. These are planning illustrations and do not turn this observational study into a randomized comparison or establish that an effect was observed.
The registry record does not report a sample-size justification for the study’s own design, and the illustration should not be described as observed power. Nor does the record report an inferential analysis corresponding to the illustration. The posted data should therefore be interpreted on their own descriptive terms.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 10 outcome measures, including the primary safety outcome and secondary outcomes concerning hormone suppression and the ratio of bone age to chronological age. It does not report a multiplicity plan, such as a strategy for controlling the chance of false-positive findings when several outcomes are examined. In general, assessing multiple outcomes can raise that concern; whether an adjustment is needed depends on the study’s aims and analysis plan. The plan is not reported in the registry record, so no claim about adjustment can be made.
Numerical results for the listed secondary outcomes are not reported in the registry record. The record also lists no statistical analysis entries. It does not report whether analyses were prespecified, whether any interim analyses occurred, or how repeated measurements and subgroup analyses were handled. Those details should not be inferred from the outcome titles.
The safety analysis set is defined as all enrolled participants, and the primary outcome is stated to be reported separately for male and female participants. Sex-specific numbers are not reported in the information available for interpretation. The record does not describe how missing outcome data, incomplete records, loss to follow-up, or participants with unobserved outcomes were handled. It does not state whether imputation or another missing-data procedure was used.
These omissions matter because the analysis population and missingness approach can affect what a result represents. The group counts at risk are reported for the posted safety figures, but those counts do not explain whether every participant had complete outcome ascertainment over the relevant period. No assumptions about missingness or subgroup results can be added without further reporting.
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 |
|---|---|---|---|
| Treatment Phase: Enantone | 2 | 108 | 1.9% |
| Follow Up: Participants No Longer Treated for CPP | 0 | 44 | 0.0% |
| Follow Up: Treated With Non-Enantone GnRHa After Enantone | 0 | 26 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment Phase: Enantone | 0 of 108 |
| Follow Up: Participants No Longer Treated for CPP | 0 of 44 |
| Follow Up: Treated With Non-Enantone GnRHa After Enantone | 0 of 26 |
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 |
|---|---|
| Treatment Phase: Enantone | 63 of 108 |
| Follow Up: Participants No Longer Treated for CPP | 0 of 44 |
| Follow Up: Treated With Non-Enantone GnRHa After Enantone | 9 of 26 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment Phase: Enantone | Follow Up: Participants No Longer Treated for CPP | Follow Up: Treated With Non-Enantone GnRHa After Enantone |
|---|---|---|---|---|
| Pneumonia | Infections and infestations | 1 of 108 | 0 of 44 | 0 of 26 |
| Hair follicle tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 108 | 0 of 44 | 0 of 26 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment Phase: Enantone | Follow Up: Participants No Longer Treated for CPP | Follow Up: Treated With Non-Enantone GnRHa After Enantone |
|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 18 of 108 | 0 of 44 | 1 of 26 |
| Growth retardation | Musculoskeletal and connective tissue disorders | 15 of 108 | 0 of 44 | 2 of 26 |
| Bronchitis | Infections and infestations | 14 of 108 | 0 of 44 | 0 of 26 |
| Pharyngitis | Infections and infestations | 13 of 108 | 0 of 44 | 1 of 26 |
| Pyrexia | General disorders | 9 of 108 | 0 of 44 | 2 of 26 |
| Refraction disorder | Eye disorders | 9 of 108 | 0 of 44 | 0 of 26 |
| Cough | Respiratory, thoracic and mediastinal disorders | 7 of 108 | 0 of 44 | 2 of 26 |
| Rhinitis | Infections and infestations | 7 of 108 | 0 of 44 | 0 of 26 |
| Tonsillitis | Infections and infestations | 7 of 108 | 0 of 44 | 0 of 26 |
| Nasopharyngitis | Infections and infestations | 4 of 108 | 0 of 44 | 0 of 26 |
Serious events with the highest arm-level rate: pneumonia (0.9%), hair follicle tumour benign (0.9%).
The Enantone treatment-phase figures report 2 participants with serious adverse events and 63 with other adverse events, each among 108 at risk; deaths were 0. The follow-up group no longer treated for CPP reports 0 serious events, 0 other events, and 0 deaths among 44 at risk. The group treated with a non-Enantone GnRHa after Enantone reports 0 serious events, 9 other events, and 0 deaths among 26 at risk.
These counts refer to participants with events, not necessarily the total number of event episodes. The registry identifies Pneumonia and Hair follicle tumour benign as top serious-event terms, each reported at 0.9%. A TEAE need not be caused by treatment under the registry definition. The event terms and counts therefore describe recorded safety experience, not causal attribution.
The follow-up groups have different treatment histories and are not randomized comparison arms. Their counts should not be treated as a direct safety ranking. In general, zero observed events in a group does not establish zero underlying risk, and raw counts do not account for differing observation time. The registry does not report confidence intervals or time-adjusted event rates for these figures.
12. What the Result Does, and Does Not, Mean
The posted results show that adverse events were recorded during Enantone treatment and in the two follow-up groups. In the treatment phase, the record reports 2 participants with serious adverse events and 63 with other adverse events among 108 at risk, with 0 deaths. Follow-up counts are also reported for participants no longer treated and for participants who continued with a non-Enantone GnRHa. These figures document what was recorded in the specified groups and periods.
They do not establish that Enantone caused the events. The registry’s TEAE definition explicitly allows events that are not necessarily causally related to treatment, and the study is observational. The record does not describe randomized allocation, and the follow-up groups are not like-for-like controls. The counts therefore cannot show how the same participants would have fared under a different treatment history.
The record also does not provide numerical results for the listed secondary outcomes on LH, FSH, estradiol or testosterone suppression, or bone-age ratio. Consequently, the safety figures do not establish effectiveness. They also do not provide a comprehensive estimate of long-term safety: follow-up durations vary, time-adjusted rates are not reported, and methods for missing data and event ascertainment are not described.
In general, statistical uncertainty is important when interpreting event counts. No confidence intervals, p-values, or adjusted estimates are reported, so the precision of comparative conclusions cannot be evaluated. Zero events observed in a follow-up group should not be read as proof that events cannot occur. The appropriate interpretation is limited to the descriptive counts and event terms recorded, within the stated exposure and follow-up context.
The record is therefore informative about the design and the reported safety observations, but it does not support a causal treatment claim, a randomized treatment comparison, or a conclusion about the listed effectiveness outcomes. Those questions would require additional outcome reporting and an analysis appropriate to the study design.
13. Why This Trial Matters Statistically
This study is statistically useful to read because it illustrates how the design shapes the claims that can be made from safety data. A retrospective observational record can describe treatment histories and recorded events across treatment and follow-up. It cannot, by itself, supply the protection against confounding that random allocation is intended to provide. The registry does not state an allocation method, and it explicitly identifies the arms as not being a like-for-like control comparison.
The counts also show why the unit of analysis and time window matter. The primary outcome concerns participants with events, while follow-up durations differ across groups. In general, a count of affected participants is not the same as an event rate adjusted for time at risk. The registry reports exposure and follow-up duration summaries but does not report time-adjusted rates or the analysis used to account for varying observation.
Another important lesson is that safety terminology is not equivalent to causality. The registry defines a TEAE as an occurrence that need not be related to treatment. Seriousness is classified by specified consequences or other significance, not by proof that the drug caused the event. Correctly separating these concepts prevents descriptive safety reporting from being overstated.
Finally, a study’s stated range of aims should be distinguished from its posted numerical results. The record lists secondary hormone and bone-age outcomes, but their numerical results are not reported. The available figures therefore address safety descriptively, not effectiveness. Recognizing that boundary is central to sound biostatistical interpretation.
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 registry record provides limited information about the methods used to assemble and analyze the retrospective data. It does not report the source of records, event ascertainment procedures, adjudication methods, or how completeness and accuracy were assessed. It also does not describe how participants with incomplete follow-up or missing outcome measurements were handled. These details affect interpretation of the counts but cannot be inferred.
The study is observational, allocation is not stated, and the described groups are not like-for-like controls. Participants in the follow-up groups differ by whether they were no longer treated or continued with another GnRHa. These features limit causal and comparative interpretations. The record does not report adjustment for potential confounding or a statistical analysis plan.
The treatment phase spans an index period from 01 September 1998 to 30 September 2018, and Enantone exposure varied, with a mean of 22.3 months and a range of 10.1 to 52.4 months. Follow-up durations also varied across the described groups. The posted participant counts are not reported as time-adjusted rates, and the record does not state how differences in observation time were incorporated in analysis.
Although the primary outcome is stated to be reported separately for male and female participants, sex-specific results are not reported in the record. Numerical results for secondary hormone and bone-age outcomes are also not reported. The registry lists no statistical analysis entries, and does not report multiplicity handling, interim analyses, or a sample-size justification for the study’s own design. These limitations leave important questions about precision, missingness, and effectiveness unanswered.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants — NCT02993926.
- Registry record last updated 2022-03-16; status last verified 2022-03.
- Results first posted 2019-10-24.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed observational, retrospective study of Enantone (leuprorelin) for central precocious puberty among Chinese participants. It lists 108 enrolled participants, a study start date of 2017-06-24, and a primary completion date of 2018-09-30. The primary outcome is the number of participants with at least one TEAE and SAE during treatment and up to 30 days after the last Enantone dose.
Posted safety figures include 2 participants with serious adverse events and 63 with other adverse events among 108 at risk during Enantone treatment, with 0 deaths. Follow-up figures are reported for participants no longer treated for CPP and those treated with a non-Enantone GnRHa after Enantone. The record lists 10 outcome measures, but numerical results for the listed secondary effectiveness outcomes and statistical analysis details are not reported in the registry record. Because allocation is not stated and the arms are not like-for-like controls, the available counts are descriptive rather than causal comparisons.