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 Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients (NCT01554956), a na phase 2, phase 3 study. The primary outcome is Percentage of Success to Prevent Pseudomembranes Relapse.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01554956 |
| Phase | Phase 2, Phase 3 |
| Condition | Ligneous Conjunctivitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Kedrion S.p.A. |
| Results posted | Yes |
2. Clinical Question
Population
Patients diagnosed with ligneous conjunctivitis. The registry lists enrollment as 12; the study summary describes treatment of at least 10 subjects and approximately 20 eyes. The registry record does not give further eligibility criteria or describe the analysis populations.
Intervention
Human Plasminogen Eye Drop treatment, using a sterile, human plasma-derived preparation for topical ocular use. The summary describes treatment for 12 to 48 weeks, with the possibility of extended treatment in a continuation segment.
Comparator
The study is described as historically controlled, open-label, and single-group. A concurrent control group or a specific historical control dataset is not reported in the registry record. Group 1A and Group 1B are described in relation to treatment course, not as a randomized comparison.
Primary question
Among treated eyes that reached the relapse-prevention segment after initial regression or surgical excision, what proportion met the predefined complete or partial success criteria for preventing pseudomembrane relapse?
The clinical question is about relapse following an initial treatment stage, rather than simply whether pseudomembranes were present at baseline or whether their surface area changed. The primary endpoint classifies outcomes as complete success, partial success, or failure. Complete success means no relapse by the end of Segment 2. Partial success includes later relapse, or the specified Group 1A circumstance in which relapse did not occur after the third cycle while the higher dose was maintained. Failure includes early relapse or failure of pseudomembranes to regress after repeat Segment 1 cycles for Group 1A.
The endpoint description specifies assessment during Segment 2, after initial total regression for Group 1A or surgical excision for Group 1B, up to 21 weeks from study start. The registry record does not report the observed success counts or percentages, so the primary question cannot be answered from the available outcome details alone.
3. Trial Design
This was an open-label, historically controlled Phase II/III study of human plasminogen eye drops in patients diagnosed with ligneous conjunctivitis. The registry describes a single-group model and lists allocation as not applicable. No random allocation or masking is reported. The study is associated with Kedrion S.p.A. and is listed as completed.
The registry lists enrollment as 12. The brief study summary describes a plan to treat at least 10 subjects, for approximately 20 eyes. These figures describe different registry entries and should not be treated as a count of eyes or as a count of participants in each analysis group. The record does not provide a detailed accounting of the number of participants or eyes contributing to each endpoint.
All subjects were to receive the investigational product for 12 to 48 weeks, with possible extended treatment in a continuation segment. The primary endpoint distinguishes Group 1A, assessed after initial total regression, from Group 1B, assessed after surgical excision. These labels identify different clinical pathways within the study description; they do not establish a randomized or like-for-like treatment comparison. A specific historical control source and its outcome data are not reported in the registry record.
The study start is listed as 2013-05-22, and primary completion as 2014-04-25. Because the study was open-label and lacked a concurrent randomized control group, the design primarily supports descriptive reporting of outcomes among treated participants. It does not, by itself, isolate treatment effects from changes over time, differences in clinical course, or other influences. The registry record does not report a detailed statistical analysis plan or explain how the historical control was intended to be used.
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: The study was divided in Part 1 (Segment 1 and Segment 2) and Part 2 (Continuation Segment). The screening procedures were performed within a 30-day window prior to receiving the first study IMP administration. A second screening for additional two subjects was performed before entering in the Part 2 of the study.
Part 1 (Segment 1 and Segment 2)
| Stage | Group 1A | Group 1B | Continuation Segment |
|---|---|---|---|
| STARTED | 4 | 7 | 0 |
| COMPLETED | 4 | 6 | 0 |
| NOT COMPLETED | 0 | 1 | 0 |
Reasons for not completing this period:
| Reason | Group 1A | Group 1B | Continuation Segment |
|---|---|---|---|
| Withdrawal by Subject | 0 | 1 | 0 |
Part 2 (Continuation Segment)
| Stage | Group 1A | Group 1B | Continuation Segment |
|---|---|---|---|
| STARTED | 4 | 6 | 1 |
| COMPLETED | 2 | 1 | 0 |
| NOT COMPLETED | 2 | 5 | 1 |
Reasons for not completing this period:
| Reason | Group 1A | Group 1B | Continuation Segment |
|---|---|---|---|
| Withdrawal by Subject | 0 | 1 | 1 |
| SUBJECT WAS WITHDRAWN BY THE INVESTIGATOR AT THE SITE FOR NON-IMP RELATED REASON | 2 | 4 | 0 |
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 | Group 1A | Group 1B | Continuation Segment | Total |
|---|---|---|---|---|---|
| Participants analysed | 4 | 7 | 1 | 12 | |
| Age, Categorical: <=18 years | Participants | 3 | 6 | 1 | 10 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 1 | 0 | 2 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 3 | 4 | 0 | 7 |
| Sex: Female, Male: Male | Participants | 1 | 3 | 1 | 5 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 4 | 7 | 1 | 12 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Success to Prevent Pseudomembranes Relapse, measured over The prevention of pseudomembranes relapse was assessed during Segment 2, after initial total regression at the end of Segment 1 (Group 1A) or after surgical excision (Group 1B) up to 21 weeks from the study start..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of eyes |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage of eyes classified as successful in preventing pseudomembrane relapse. Assessment took place during Segment 2 after initial total regression at the end of Segment 1 for Group 1A, or after surgical excision for Group 1B, with follow-up described up to 21 weeks from study start.
Success is divided into complete and partial categories. Complete success means no relapse by the end of Segment 2. Partial success includes relapse appearing 2 weeks or longer after Segment 2 begins, and a specified Group 1A situation involving the third Segment 2 cycle, no relapse, and maintenance of the higher dose. Failure includes relapse within 2 weeks of Segment 2 beginning, or, for Group 1A after repeat Segment 1 cycles, lack of regression following Segment 1.
This endpoint is used to describe whether relapse was prevented or delayed after an initial response or excision. The registry says the primary endpoint was presented descriptively and that confidence intervals were calculated for the relapse rate corresponding to complete success and to complete plus partial success. The record does not report the resulting counts, percentages, or confidence interval limits. It therefore documents how success was defined but not the observed primary endpoint estimate.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives the study design and endpoint definitions, but it does not report the primary outcome estimates. There are no observed counts or percentages for complete success, partial success, or failure, and no confidence interval limits are stated. Consequently, the extent of relapse prevention in the treated study population cannot be assessed from the endpoint information in the record.
The primary outcome was intended to be summarized descriptively. Complete success represents no relapse through the end of Segment 2. The combined complete-plus-partial category includes outcomes in which relapse occurred later, as well as the specified Group 1A circumstance without relapse under the stated dosing condition. These categories answer different descriptive questions: the complete-success measure is stricter, while the combined measure also counts outcomes meeting the partial-success definition. Without their observed values, neither can be interpreted quantitatively.
The study’s historically controlled, single-group, open-label design also limits causal interpretation. A historical comparison is not equivalent to concurrent random allocation: differences between study participants and historical patients, changes in clinical care, or other factors could contribute to apparent differences. The registry record does not identify the historical control dataset or report an adjusted comparison. The Group 1A and Group 1B descriptions reflect distinct treatment pathways, not evidence of a randomized comparison between them.
The posted safety figures describe serious and other adverse events by study group or segment. They are useful for understanding what the registry recorded during those periods, but the entries do not establish that an event was caused by the study treatment. The record does not provide event timing, exposure-adjusted rates, or details needed to compare risk across the groups or segments. The listed groups also should not be combined: the record does not establish that they are mutually exclusive or represent independent sets of participants.
Any sample-size planning illustrations based on an observed effect are planning exercises, not observed power and not evidence that the study had a particular probability of detecting an effect. The registry record does not provide primary endpoint estimates with which to judge precision, and it does not report a sample-size justification or full statistical plan. The available information therefore supports a careful description of the study structure and recorded safety counts, but not a numerical conclusion about the primary efficacy endpoint or a causal treatment effect.
9. Statistical Methods Explained
The registry describes a descriptive primary endpoint and binomial confidence intervals. These methods can communicate the observed frequency of a defined outcome and the uncertainty around that frequency. However, the registry record does not report the endpoint counts, percentages, or interval limits, so the actual precision of the primary estimate cannot be evaluated from the recorded details.
What does a confidence interval communicate?
In general, a confidence interval expresses uncertainty around an estimate under the assumptions of the statistical method. For a binomial outcome, the underlying idea is that each assessed unit falls into one of two categories for a given calculation, such as meeting or not meeting a specified success definition. The interval reflects uncertainty associated with estimating the proportion from the observed data. It is not a guarantee that the true value lies within the particular calculated interval, and it does not address biases arising from study design or outcome assessment.
Here, the endpoint description says that 95% confidence intervals were calculated for the relapse rate corresponding to complete success and to complete plus partial success, assuming a binomial distribution. The registry record does not state the particular interval procedure, nor does it provide the number of eyes contributing to either estimate. No interval should therefore be reconstructed from the description alone. The stated assumption also does not make observations independent if multiple eyes belong to the same subject; whether or how within-subject dependence was addressed is not reported in the registry record.
Why does the endpoint use categories?
The endpoint separates outcomes according to both whether relapse occurred and when it occurred relative to Segment 2, with an additional specified condition for Group 1A. This produces clinically defined categories rather than a single continuous measurement. Complete success and complete-plus-partial success are related but not interchangeable summaries. A later relapse may qualify as partial success even though it is not complete success. The registry says these responses were tabulated for the mITT and Per Protocol populations, but it does not define those populations or provide their results.
General statistical interpretation should account for the fact that category definitions determine what is counted as success. If definitions differ in timing or treatment pathway, the resulting proportions describe those operational definitions. They should not be read as a general measure of all aspects of disease course. The registry provides definitions, but it does not report an independent outcome-adjudication process or masking of assessors.
What does descriptive analysis mean?
In general, a descriptive analysis reports the observed data without using a model to estimate a treatment effect relative to a comparator. It can show how many assessed units fell into each outcome category and quantify uncertainty around proportions. It does not, on its own, determine what would have happened to the same patients without treatment. This distinction matters in a single-group study with historical control context and no concurrent randomized comparison.
The registry characterizes the primary endpoint as descriptive. It lists six outcome measures and no analysis entries. That does not mean no analysis was conducted outside the registry record; it means that analysis results are not reported in the record described. A full statistical analysis plan, including any adjustment methods or prespecified comparisons, is not reported in the registry record.
How should planning illustrations be read?
In general, sample-size calculations use assumptions about the outcome, variability, significance level, allocation, and effect to be detected. A planning illustration based on an observed effect asks what sample size might be needed under specified assumptions; it is not a measure of the study’s observed power. Observed power is not a substitute for interpreting the estimate and its uncertainty. The planning assumptions stated for this study use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect expressed as a fraction of the observed effect. The record does not report a trial-specific sample-size justification. Since the design is single-group and the registry identifies no like-for-like control comparison, planning calculations framed around two arms should be understood as illustrations rather than a description of the enrolled design.
For general context, over-dispersion means that observed variability is greater than a model’s assumed variability. If present, a model that assumes too little variation can make uncertainty appear smaller than it is. The registry record does not report an over-dispersion assessment or a model of this kind for the primary endpoint. No such adjustment should be assumed.
The adverse-event entries are counts with “at risk” and “affected” labels, while the listed event terms include percentages. These summaries are not the primary endpoint’s binomial confidence intervals. The registry record does not define the percentage denominators for the listed serious-event terms or provide enough detail to infer them. Interpret each item as a registry-reported safety summary, not as a causal effect estimate.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures, including the primary endpoint and a secondary outcome concerning the percentage of eyes with regression in surface area of existing ligneous pseudomembranes. The record does not describe a multiplicity-control strategy, such as a method for accounting for the possibility of findings across several outcomes. It also does not report whether any outcomes were designated as exploratory or how inference across outcomes was intended to be handled. Without that information, nominal uncertainty measures for separate outcomes should not be taken as evidence that multiplicity was addressed.
The primary endpoint description says responses were tabulated for the mITT and Per Protocol populations. Definitions of those populations, including criteria for inclusion or exclusion, are not reported in the registry record. The record does not state whether the primary analysis population was chosen in advance or how participants with incomplete endpoint information were handled.
Missing-data methods are not reported in the registry record. In particular, the record does not explain how eyes or participants with missing Segment 2 assessments, early discontinuation, or incomplete follow-up would contribute to the success categories or denominator. It also does not describe sensitivity analyses for missing outcomes. These omissions prevent assessment of whether the reported analysis, if conducted, might be sensitive to incomplete follow-up.
The registry lists no analysis entries, and it does not provide numerical primary endpoint results. It is therefore not possible to verify consistency between outcome definitions, analysis populations, missing-data handling, and reported estimates from the record alone. No imputation method, multiplicity adjustment, or analysis-population rule should be inferred.
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 |
|---|---|---|---|
| Group 1A | 2 | 4 | 50.0% |
| Group 1B | 3 | 7 | 42.9% |
| Continuation Segment | 3 | 11 | 27.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Group 1A | 0 of 4 |
| Group 1B | 0 of 7 |
| Continuation Segment | 0 of 11 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Group 1A | 4 of 4 |
| Group 1B | 7 of 7 |
| Continuation Segment | 10 of 11 |
Most frequent serious adverse event terms
| Event term | Organ system | Group 1A | Group 1B | Continuation Segment |
|---|---|---|---|---|
| Blood alkaline phosphatase increased | Investigations | 1 of 4 | 1 of 7 | 0 of 11 |
| Drug specific antibody present | Investigations | 0 of 4 | 1 of 7 | 1 of 11 |
| Conjunctivitis | Eye disorders | 0 of 4 | 0 of 7 | 1 of 11 |
| Autoimmune hepatitis | Hepatobiliary disorders | 1 of 4 | 0 of 7 | 0 of 11 |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 0 of 4 | 0 of 7 | 1 of 11 |
| Varicella | Infections and infestations | 0 of 4 | 1 of 7 | 0 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group 1A | Group 1B | Continuation Segment |
|---|---|---|---|---|
| Pyrexia | General disorders | 3 of 4 | 3 of 7 | 7 of 11 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3 of 4 | 2 of 7 | 6 of 11 |
| Antibody test positive | Investigations | 0 of 4 | 4 of 7 | 4 of 11 |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 2 of 4 | 1 of 7 | 3 of 11 |
| Ear infection | Infections and infestations | 1 of 4 | 0 of 7 | 5 of 11 |
| Nasopharyngitis | Infections and infestations | 0 of 4 | 1 of 7 | 5 of 11 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 3 of 4 | 0 of 7 | 2 of 11 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 0 of 4 | 0 of 7 | 4 of 11 |
| Headache | Nervous system disorders | 1 of 4 | 1 of 7 | 2 of 11 |
| Ocular hyperaemia | Eye disorders | 0 of 4 | 1 of 7 | 3 of 11 |
Serious events with the highest arm-level rate: blood alkaline phosphatase increased (25.0%), autoimmune hepatitis (25.0%), drug specific antibody present (14.3%), varicella (14.3%), conjunctivitis (9.1%).
The registry reports serious and other adverse-event counts separately for Group 1A, Group 1B, and the Continuation Segment. For serious events, the entries list 4 at risk and 2 affected in Group 1A; 7 at risk and 3 affected in Group 1B; and 11 at risk and 3 affected in the Continuation Segment. For other events, the corresponding entries are 4 at risk and 4 affected, 7 at risk and 7 affected, and 11 at risk and 10 affected. The death count is listed as 0 for each group or segment.
These are registry counts, not a comparison of treatment with a control group. The record does not explain whether participants appear in more than one segment or group, so the group entries should not be added together. It also does not give event-level timing, duration, severity beyond the serious-versus-other classification, or a causal assessment. The at-risk labels identify the registry’s stated denominator for each entry, but further details about exposure and counting rules are not reported.
The registry lists serious-event terms with percentages, including Blood alkaline phosphatase increased and Autoimmune hepatitis at 25.0% each, and Drug specific antibody present and Varicella at 14.3% each. It also lists Conjunctivitis and Diabetic ketoacidosis at 9.1% each. The record does not specify the denominator or group assignment for these term-specific percentages. They should not be interpreted as treatment-attributable risks or compared directly with the group-level counts without that context.
12. What the Result Does, and Does Not, Mean
The registry record establishes that an open-label, single-group study of human plasminogen eye drops was conducted in patients diagnosed with ligneous conjunctivitis and that relapse prevention was defined as the primary endpoint. It also records the study’s success categories, the intended assessment period, and adverse-event counts. These details clarify what the investigators planned to measure and what safety summaries were entered.
The available record does not state how many eyes met complete success, partial success, or failure criteria. It does not provide the primary endpoint percentages or confidence interval limits. Therefore, no numerical conclusion about the frequency of relapse prevention, the size of uncertainty around it, or the relationship between outcomes and treatment can be drawn from the information reported.
The design does not include a concurrent randomized comparator in the registry description. A historically controlled context does not remove the possibility that differences in patient characteristics, follow-up, clinical practice, or outcome ascertainment could affect comparisons. The record does not name the historical control data or provide an analysis comparing those data with study outcomes. Group 1A and Group 1B should not be treated as randomized arms.
The safety entries show recorded adverse-event counts in the listed groups or segments, including zero deaths in each entry. They do not establish that events were caused by the study treatment, and the listed percentages for specific serious-event terms lack a reported denominator in the registry record. Nor do the figures, without exposure and overlap details, support a direct comparison among the segments.
In general, a trial record can be informative about design and outcome definitions even when results are incomplete. In this case, it supports understanding of the intended relapse-prevention measure and the recorded safety summaries. It does not support a definitive statement about treatment benefit, lack of benefit, comparative effectiveness, or the causal interpretation of adverse events.
13. Why This Trial Matters Statistically
This study is statistically notable for the gap between a detailed endpoint definition and the absence of reported primary endpoint estimates in the registry record. The endpoint specifies distinct success and failure categories, identifies the follow-up context, and states that binomial confidence intervals were used. Yet without the observed counts, percentages, and interval limits, readers cannot evaluate either the magnitude of the result or its precision.
The design also illustrates why the label “historically controlled” needs careful interpretation. The registry describes a single-group, open-label study and does not identify the historical control source or report a comparison analysis. Historical data can provide context, but they do not create the balance and concurrent follow-up associated with randomized allocation. The Group 1A and Group 1B pathways represent different clinical circumstances and should not be mistaken for a controlled treatment contrast.
The unit of analysis is another important consideration. The summary refers to subjects and approximately 20 eyes, while the primary endpoint is expressed as a percentage of eyes. If multiple eyes from the same person contribute, their outcomes may be related. Whether this dependence was addressed is not reported in the registry record. The record also does not define the mITT or Per Protocol populations or explain handling of missing eye-level assessments.
Finally, the registry includes safety counts across groups and a continuation segment, but does not explain overlap, exposure time, or the denominator for term-specific percentages. These details matter when interpreting rates and comparing summaries. The record therefore provides useful statistical context about measurement and reporting, while leaving important information needed for estimates, precision, and comparative interpretation unreported.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation is that numerical results for the primary endpoint are not reported in the registry record. Although the outcome definition and confidence-interval approach are described, the observed response counts, percentages, and interval limits are absent. This prevents assessment of the primary endpoint’s size and precision.
The study is open-label and single-group, with historical control context but no concurrent comparator described. The registry does not identify the historical data source, explain comparability, or report a formal comparison. As a result, a treatment effect cannot be separated from other differences or changes that may affect outcomes.
The registry refers to outcomes measured per eye and to treatment of subjects, but does not report the number of eyes contributing to each analysis or how within-subject dependence was handled. It also does not define the mITT and Per Protocol populations. Missing-data rules, analysis-population selection, and sensitivity analyses are not reported in the registry record.
Safety summaries are divided by group or segment, but the record does not clarify whether these categories overlap, give exposure-adjusted summaries, or identify the denominators for the percentages attached to specific serious-event terms. The event counts cannot establish causation and should not be treated as directly comparable rates across segments.
The registry record also does not report a detailed statistical analysis plan, a trial-specific sample-size justification, or a multiplicity strategy. These omissions limit assessment of how analyses were prespecified and how uncertainty across outcomes was intended to be interpreted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients — NCT01554956.
- Registry record last updated 2023-01-25; status last verified 2022-06.
- Results first posted 2023-01-25.
- 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
NCT01554956 is a completed, open-label, historically controlled Phase II/III study of human plasminogen eye drops for ligneous conjunctivitis. The registry lists enrollment as 12 and describes treatment for 12 to 48 weeks, with possible continuation. The primary endpoint concerns eye-level success in preventing pseudomembrane relapse after initial regression or surgical excision.
The endpoint description defines complete success, partial success, and failure, and states that 95% binomial confidence intervals were calculated for specified success summaries. The registry record does not report the resulting primary outcome counts, percentages, or interval limits. It lists six outcome measures and no analysis entries.
Adverse-event counts are reported for Group 1A, Group 1B, and the Continuation Segment, with 0 deaths listed for each. The record does not provide sufficient detail to establish causality, compare segments, or interpret the denominators for the listed serious-event percentages. Overall, the registry documents the study structure and measurement definitions but does not report the numerical primary efficacy results needed to assess the endpoint.