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 Prospective Clinical Evaluation of BD Spinal Needles (NCT05214560), a registered phase not stated study. The primary outcome is Primary Safety: Incidence of Post-dural Puncture Headache (PDPH)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05214560 |
| Phase | Phase not stated |
| Condition | Analgesia, Anesthesia |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 160 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Becton, Dickinson and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants who required a BD Spinal needle and received a neuraxial procedure were eligible for the study population described in the record. Enrollment was 160. For the primary safety calculation, the record describes 142 participants with successful placement of the study device as the safety set; it also states that 144 participants received a neuraxial procedure. These figures describe different stages or populations in the record and should not be treated as interchangeable.
Intervention
The intervention was use of a BD Spinal needle in an on-market fashion. The study is described as a post-market, observational evaluation of real-world safety and efficacy. The record names the intervention as a device and does not describe an assigned treatment protocol or a comparison intervention.
Comparator
No comparator group is listed. The record identifies all participants as the study arm, and its allocation is not stated. Consequently, the study does not provide a like-for-like control comparison for estimating a relative difference between devices or procedures.
Primary question
The primary safety outcome was the incidence of post-dural puncture headache (PDPH), expressed as the percentage of participants with a PDPH diagnosis from insertion up to 7 days post procedure. The record specifies a 95% confidence interval, but the observed primary outcome value and its interval are not reported in the registry record. The clinical question is therefore identifiable, while its reported answer is not.
3. Trial Design
The registry record describes a prospective, post-market, observational study of BD Spinal Needles. Its stated aim was to assess real-world safety and efficacy when the device was used in an on-market fashion. The study status is completed. The recorded start date is 2022-02-14 and the primary completion date is 2022-07-22. Enrollment was 160.
The intervention is a spinal needle, classified as a device. The arm description is “Participants who require a BD Spinal needle,” and the listed arm is “All Participants.” No comparator arm is described, and allocation is not stated. This design can describe outcomes among the observed participants, but it does not establish a randomized contrast or a controlled estimate of relative effects. The record itself flags that the arms are not a like-for-like control comparison.
The primary endpoint concerns PDPH after the anesthesia procedure. Its timeframe extends from insertion up to 7 days post procedure. The registry states that 144 participants received a neuraxial procedure and that 142 participants had successful placement of the study device and were included in the safety set used for the primary safety calculation. The primary analysis population is therefore described in the record, although the actual primary result is not.
Secondary safety outcomes listed in the record include spinal or epidural hematoma, nerve damage described as pain or weakness in the lower extremities, infection including meningitis or spinal abscess, pain or skin irritation near the puncture site, and backache. The record lists 10 outcome measures but does not report analysis entries. Details such as a protocol, recruitment procedures, eligibility criteria beyond the stated needle requirement, or a statistical analysis plan 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.
Before assignment: The choice of the specific BD Spinal Needle type, size, and length required for an individual participant was left to the discretion of the clinician. In this post market study, 160 participants, who were to receive a neuraxial procedures with a BD Spinal Needle as per routine clinical practice, were observed through 7-days post procedure to assess for adverse events/complications.
Overall Study
| Stage | All Participants |
|---|---|
| STARTED | 160 |
| Enrolled Set | 160 |
| Evaluable Set | 144 |
| Safety Set | 142 |
| COMPLETED | 142 |
| NOT COMPLETED | 18 |
Reasons for not completing this period:
| Reason | All Participants |
|---|---|
| Screening Failure | 1 |
| Physician Decision | 4 |
| Withdrawal by Subject | 1 |
| Lost to Follow-up | 2 |
| General anesthesia at the request of the surgeon | 2 |
| Study physician not available for the anesthesia | 3 |
| Anesthesia rejected by the patient on the day of surgery | 1 |
| Device not listed in the study was used for the procedure | 1 |
| Surgery not performed | 3 |
Analysis population for the primary outcome, as defined in the registry: Out of 144 participants who received a neuraxial procedure, a total of 142 participants received a successful placement of the study device and were included in the safety set, used for the primary safety calculation.
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: 160 subjects signed informed consent (Enrolled Set). 1 subject was screening failure due to "Previous spine surgery at level involved in the study procedure" and 144 subjects underwent a neuraxial procedure, regardless of success (Evaluable Set). The Evaluable set has been considered for the baseline analysis population.
| Characteristic | Unit | All Participants |
|---|---|---|
| Participants analysed | 144 | |
| Age, Continuous | years | 55.5 (SD 18.01) |
| Sex: Female, Male: Female | Participants | 52 |
| Sex: Female, Male: Male | Participants | 92 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 143 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: Austria | participants | 5 |
| Region of Enrollment: Finland | participants | 35 |
| Region of Enrollment: Germany | participants | 73 |
| Region of Enrollment: Spain | participants | 31 |
| Body Max Index | kg/m^2 | 27.51 (SD 4.934) |
| Primary diagnosis for intervention: Surgery of lower extremities | Participants | 65 |
| Primary diagnosis for intervention: Surgery of lower abdomen | Participants | 16 |
| Primary diagnosis for intervention: Surgery of perineum | Participants | 2 |
| Primary diagnosis for intervention: Surgery of hips and pelvis | Participants | 9 |
| Primary diagnosis for intervention: Obstetric | Participants | 5 |
| Primary diagnosis for intervention: Other | Participants | 47 |
| Reason for neuraxial procedure: Reason for neuraxial procedure:anesthesia | Participants | 144 |
| Reason for neuraxial procedure: Reason for neuraxial procedure:analgesia | Participants | 0 |
| Reason for neuraxial procedure: Reason for neuraxial procedure: other | Participants | 0 |
| American Society of Anesthesiologists (ASA) physical status (PS) classification: ASA PS Classification I | Participants | 39 |
| American Society of Anesthesiologists (ASA) physical status (PS) classification: ASA PS Classification II | Participants | 82 |
| American Society of Anesthesiologists (ASA) physical status (PS) classification: ASA PS Classification III | Participants | 23 |
| Spinal needle placement details- Participant position during spinal needle procedure: Lateral position | Participants | 39 |
| Spinal needle placement details- Participant position during spinal needle procedure: Sitting position | Participants | 105 |
| Spinal needle placement details - Aseptic technique: Aseptic technique = Chlorhexidine | Participants | 26 |
| Spinal needle placement details - Aseptic technique: Aseptic technique = Betadine | Participants | 6 |
| Spinal needle placement details - Aseptic technique: Aseptic technique = Other | Participants | 112 |
| Spinal needle placement details - Local anesthesia: Local anesthesia = Lidocaine 1% | Participants | 105 |
| Spinal needle placement details - Local anesthesia: Local anesthesia = Lidocaine 2% | Participants | 5 |
| Spinal needle placement details - Local anesthesia: Local anesthesia = Other | Participants | 34 |
| Spinal needle placement details - Lumbar interspace: L2-L3 | Participants | 12 |
| Spinal needle placement details - Lumbar interspace: L3-L4 | Participants | 104 |
| Spinal needle placement details - Lumbar interspace: L4-L5 | Participants | 27 |
| Spinal needle placement details - Lumbar interspace: Other | Participants | 1 |
| Spinal needle placement details - Number of Puncture attempts: Number of Puncture attempts = 1 | Participants | 136 |
| Spinal needle placement details - Number of Puncture attempts: Number of Puncture attempts = 2 | Participants | 3 |
| Spinal needle placement details - Number of Puncture attempts: Number of Puncture attempts = 3 | Participants | 3 |
| Spinal needle placement details - Number of Puncture attempts: Number of Puncture attempts = 4 | Participants | 2 |
| Spinal needle placement details - Number of Interspace levels attempts: Number of Interspace levels attempts = 1 | Participants | 132 |
| Spinal needle placement details - Number of Interspace levels attempts: Number of Interspace levels attempts = 2 | Participants | 10 |
| Spinal needle placement details - Number of Interspace levels attempts: Number of Interspace levels attempts = 3 | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Primary Safety: Incidence of Post-dural Puncture Headache (PDPH)., measured over From insertion up to 7 days post procedure.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | % of subjects with a PDPH |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants diagnosed with post-dural puncture headache (PDPH) after the anesthesia procedure. The stated observation window is from insertion up to 7 days post procedure. The record specifies that the outcome is a percentage of subjects with PDPH and that its dispersion is to be described with a 95% confidence interval.
As a general statistical explanation, a binary endpoint records whether each participant experienced the event or did not. Reporting the proportion with the event gives an absolute description of how often the recorded outcome occurred in the analysis population. A confidence interval communicates uncertainty around that estimated proportion: it gives a range of values compatible with the observed data under the assumptions of the interval method. It is not a guarantee that the true value lies within that range.
The endpoint is used as a safety measure because the study’s stated purpose includes evaluating real-world safety, and PDPH is the named primary safety outcome. The record identifies the safety set as participants with successful device placement. However, it does not report the number of PDPH diagnoses, the resulting percentage, or the confidence interval. Those results are not reported in the registry record, so the endpoint’s observed frequency and precision cannot be interpreted from the information recorded.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record defines a clinically interpretable primary safety question: how often PDPH was diagnosed from insertion up to 7 days after the procedure among participants with successful placement of the study device. It also specifies a 95% confidence interval as the measure of precision. But the registry record does not report the primary event count, the estimated percentage, or the confidence interval. Without those results, it is not possible to describe the observed primary outcome rate or how precisely it was estimated.
The population descriptions require care. The record says that 144 participants received a neuraxial procedure, while 142 participants had successful device placement and were included in the safety set for the primary safety calculation. The primary endpoint’s analysis population is thus identified as the safety set, rather than all participants enrolled. The record does not explain the difference between these populations or describe the outcomes of participants who were not included in the safety set.
Safety-event information is reported separately: the adverse-event summary lists 0 serious events among 144 at risk, 17 other events among 144 at risk, and 0 deaths. These figures should not be read as the primary PDPH result. The registry record does not identify the 17 other events as PDPH diagnoses, and it does not provide event-level detail in the serious-event terms list. A reader should therefore keep the adverse-event summary distinct from the named primary endpoint.
The study is observational and has no listed comparator group. Its results, if reported, could describe outcomes in the participants observed under on-market use, but the design does not support a direct randomized comparison with another device or procedure. The record also does not state allocation or describe a control condition. Consequently, it cannot establish comparative safety from a between-group contrast.
Even if a primary proportion and confidence interval were available, interpretation would depend on the completeness of outcome ascertainment during the stated follow-up window, the definition and diagnosis of PDPH, and which participants were included in analysis. These details are not reported in the registry record. The available record therefore supports an account of the study question and design, but not a conclusion about the observed frequency of PDPH or the strength of evidence concerning that frequency.
9. Statistical Methods Explained
The endpoint is binary: for each participant in the relevant analysis population, the outcome is whether PDPH was diagnosed during the stated window. The registry expresses the result as a percentage of participants with the outcome. This is an absolute event frequency, not a comparison between treatments. The registry record specifies a 95% confidence interval, but does not give the observed percentage or interval.
What does a confidence interval communicate?
As a general statistical explanation, an interval around an estimated proportion conveys sampling uncertainty. If the same underlying process could be observed repeatedly in comparable samples, the estimated proportion would vary from sample to sample. An interval method uses the observed data and its assumptions to describe a range that reflects this uncertainty. A narrower interval generally indicates greater precision than a wider one, while the interval does not account automatically for every possible source of bias or measurement error.
The confidence level is not the probability that a fixed underlying event rate lies in a particular calculated interval. It describes the long-run performance of the procedure under its assumptions. Interpretation also depends on how the outcome was defined, how completely it was measured, and whether the analysis population represents the population to which the result is meant to apply. Since the actual primary interval is not reported in the registry record, its width and implications cannot be assessed.
What does a binary outcome estimate?
For a binary outcome, the estimated proportion is based on the number of participants with the event relative to the relevant analysis population. The record identifies the primary safety set as participants with successful device placement, and gives that set as 142 participants. It separately states that 144 participants received a neuraxial procedure. No event count for PDPH is reported, so no event proportion can be interpreted from the primary endpoint description alone. It would be inappropriate to substitute an adverse-event count for that missing endpoint result.
In general, a proportion is most informative when the numerator and denominator refer to the same defined population and outcome window. The denominator must correspond to participants whose outcome status was assessed or otherwise handled under the analysis plan. Missing outcome status can affect interpretation; the registry record does not describe missing data handling or whether all participants in the safety set had complete follow-up through the stated window.
Why does over-dispersion matter?
As a general concept, over-dispersion arises when observed variation is greater than a statistical model assumes. For a simple binary proportion, the model and interval method should reflect the outcome structure and the sampling process. In broader event-rate analyses, ignoring extra variation can make uncertainty appear smaller than it is. The record does not describe an over-dispersion model or state that one was needed. No claim about its use in this study can be made.
What can the observational design estimate?
In general, an observational study can describe outcomes among the participants observed under the practices in which they received care. Because this record lists no comparator and states that allocation is not stated, it does not establish a randomized contrast. Differences between observed groups, if any were present, would not automatically be attributable to the device; in this record, no comparison group is specified at all. A descriptive event frequency and a causal treatment effect are different statistical quantities.
The registry record identifies a 95% confidence interval for the primary endpoint but does not state the interval procedure or a broader statistical analysis plan. The analysis count is 0. Details of adjustment, model selection, handling of covariates, or interim analyses are not reported in the registry record. Those methods should not be inferred from the stated endpoint or from the study’s observational label.
How should planning illustrations be read?
As a general distinction, a sample-size planning illustration describes the number of participants per arm that a hypothetical future study might require under selected assumptions. The record’s stated assumptions for such illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a fraction of the observed effect. The record explicitly characterizes these as planning illustrations computed from the observed effect, not as the trial’s own design. They are not observed power and do not show that this observational evaluation was planned or conducted as a two-arm comparison.
For this study, the planning assumptions cannot be treated as evidence of a prespecified design. The registry record does not report a sample-size justification or a statistical plan. Since the primary outcome estimate is also not reported, the clinical meaning of planning scenarios based on an observed effect cannot be evaluated from the registry information described in the endpoint record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 10 outcome measures and identifies one primary safety endpoint, with secondary outcomes addressing several additional safety events. It reports 0 analysis entries. The record does not explain how the different outcomes were prioritized beyond naming the primary endpoint, or whether any adjustment for multiple testing was planned or performed. Multiplicity procedures and their rationale are not reported in the registry record.
As a general statistical point, assessing several outcomes can increase the chance that at least one apparently notable result arises by chance when each is tested separately. Whether that issue matters, and how it should be addressed, depends on the planned analyses and the role assigned to each outcome. The record does not provide enough analysis detail to determine how multiplicity was handled. No adjustment should be assumed.
The primary safety calculation is described as using the safety set of 142 participants with successful device placement. The record also states that 144 participants received a neuraxial procedure. It does not report why the populations differ, whether there were exclusions or unsuccessful placements, or how such cases were handled for other outcomes. The number enrolled was 160, but the record does not give a complete flow of participants from enrollment through each analysis population.
Missing outcome data, loss to follow-up, and the handling of participants without an assessed PDPH status are not reported in the registry record. The record gives the primary follow-up window as up to 7 days post procedure but does not describe how outcome ascertainment was conducted within that period or whether incomplete follow-up occurred. These omissions limit assessment of the completeness and potential representativeness of the reported safety set. They also prevent evaluation of whether the primary estimate, if available elsewhere, would depend on assumptions about missing outcomes.
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 |
|---|---|---|---|
| All Participants | 0 | 144 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| All Participants | 0 of 144 |
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 |
|---|---|
| All Participants | 17 of 144 |
Most frequent non-serious adverse event terms
| Event term | Organ system | All Participants |
|---|---|---|
| Hypotension | Vascular disorders | 5 of 144 |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | 4 of 144 |
| Back pain | Musculoskeletal and connective tissue disorders | 3 of 144 |
| Headache | Nervous system disorders | 3 of 144 |
| Procedural failure | General disorders | 1 of 144 |
| Rhinitis | Infections and infestations | 1 of 144 |
| Injection site irritation | Injury, poisoning and procedural complications | 1 of 144 |
| Puncture site pain | Injury, poisoning and procedural complications | 1 of 144 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 1 of 144 |
| Paresthesia | Skin and subcutaneous tissue disorders | 1 of 144 |
The adverse-event summary lists 0 serious events among 144 participants at risk, 17 other events among 144 participants at risk, and 0 deaths. The serious-event terms list is empty. These are adverse-event summary figures and should be read separately from the primary PDPH endpoint, whose event count and estimated percentage are not reported in the registry record.
The record does not define the “other” category in enough detail to identify the events it contains, and it does not provide event-level descriptions for those 17 events. It would therefore be unsupported to label them as PDPH or as any particular secondary safety outcome. The record also does not explain how the adverse-event population relates to the 142 participants in the primary safety set.
As a general statistical point, observing no serious events in a study does not establish that the underlying risk is zero. The precision of a safety estimate depends on the size and composition of the population observed, the duration and completeness of surveillance, and how events were defined and collected. The registry record does not report a confidence interval for these adverse-event figures or further detail on surveillance. The reported counts are descriptive, not proof that serious events cannot occur.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed, prospective, observational post-market evaluation of BD Spinal Needles. It states that the study aimed to assess real-world safety and efficacy. Its primary safety question is well defined in broad terms: the percentage of participants diagnosed with PDPH from insertion up to 7 days post procedure, with a 95% confidence interval specified. The record identifies 142 participants with successful device placement as the safety set for that calculation.
The record does not report the primary endpoint result. It gives no PDPH event count, estimated percentage, or confidence interval. As a result, the frequency of PDPH in the stated safety set and the precision of that frequency cannot be described from the registry record. The adverse-event summary, including 0 serious events and 17 other events among 144 at risk, does not fill this gap because the record does not identify those other events as PDPH.
The study’s observational design also limits what can be inferred. No comparator group is listed, and allocation is not stated. The record therefore does not provide a controlled estimate of whether outcomes differ between devices or procedures. Descriptive outcomes from participants receiving a device in on-market use are not equivalent to evidence from a randomized comparison, and they do not by themselves establish that the device caused an outcome.
The record does not report enough information to assess outcome ascertainment, missing data, or the reasons for the differing participant populations described for the primary safety calculation and adverse-event summary. Those details matter when judging whether observed safety information is complete and how broadly it can be interpreted.
In short, the registry record identifies the study’s purpose, population descriptions, primary endpoint, and certain adverse-event counts. It does not report the primary result needed to answer the stated PDPH question. The record supports a description of what was evaluated, but not a conclusion about the observed PDPH rate or comparative safety.
13. Why This Trial Matters Statistically
This study is statistically notable because it asks a focused safety question in a post-market, observational setting. The primary endpoint is a binary event, PDPH, defined within a stated follow-up window and intended to be reported as a percentage with a 95% confidence interval. That format would communicate both the observed frequency and the uncertainty around it, provided the event count and analysis population were reported.
The record also illustrates why denominators and analysis populations need explicit interpretation. It describes 160 enrolled participants, 144 participants who received a neuraxial procedure, and 142 participants with successful placement who entered the primary safety set. Each count refers to a different stated population. The registry does not explain the transition between them, so readers should not treat them as a single interchangeable denominator.
Another statistical issue is the distinction between outcome categories. The adverse-event summary reports serious and other events, while the primary endpoint is specifically PDPH. Without an explicit link between those categories and the primary outcome, counts from one summary cannot stand in for the primary endpoint result. Clear endpoint-specific reporting is essential to prevent misinterpretation.
Finally, the study is observational and has no listed comparator. It can be understood as an evaluation of outcomes under on-market use, not as a randomized test of relative effects. The registry record’s missing primary result and limited analysis detail show why study design, event definitions, denominators, and uncertainty measures all need to be considered together. Here, the question is specified, but the information needed to assess its numerical answer is not reported in the registry record.
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 consequential limitation in the registry record is that the primary PDPH result is not reported. Although the endpoint, observation window, safety set, and intended confidence interval are described, the event count, percentage, and interval are absent. The stated primary safety question therefore cannot be answered from the registry information.
The population counts are not fully reconciled. The record describes 144 participants receiving a neuraxial procedure and 142 with successful placement included in the primary safety set, while enrollment was 160. The reasons for these differences, the outcomes of participants outside the primary safety set, and the participant flow for secondary outcomes are not reported in the registry record.
The record does not describe the diagnostic criteria for PDPH, the process for assessing the outcome, or whether follow-up was complete through 7 days post procedure. Missing data handling and sensitivity analyses are also not reported. These gaps limit interpretation of how reliably the endpoint was measured and whether the analysis population captures all relevant outcomes.
No comparator is listed, and allocation is not stated. The study therefore lacks a specified like-for-like control group for a comparative estimate. The adverse-event summary provides 0 serious events, 17 other events, and 0 deaths among the stated population at risk, but does not give event details or explain how its population relates to the primary safety set.
The registry record does not report a statistical analysis plan, a sample-size justification, or multiplicity procedures. These omissions make it difficult to evaluate prespecification and the intended handling of multiple outcomes. They do not establish that such procedures were absent; their details are simply not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Prospective Clinical Evaluation of BD Spinal Needles — NCT05214560.
- Registry record last updated 2024-08-19; status last verified 2024-03.
- Results first posted 2024-08-19.
- 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
The completed study, titled “Prospective Clinical Evaluation of BD Spinal Needles,” is described as a prospective, post-market observational evaluation of real-world safety and efficacy during on-market use. Enrollment was 160. The recorded start date was 2022-02-14, and the primary completion date was 2022-07-22.
The primary safety endpoint was the percentage of participants diagnosed with PDPH from insertion up to 7 days post procedure. The record states that 142 participants with successful placement were included in the primary safety set, among 144 participants who received a neuraxial procedure. The primary event count, percentage, and 95% confidence interval are not reported in the registry record.
The adverse-event summary lists 0 serious events, 17 other events, and 0 deaths among 144 at risk. The study has no listed comparator, allocation is not stated, and analysis details, missing-data handling, and multiplicity procedures are not reported in the registry record.