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 Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy (NCT01910298), a non-randomized na study. The primary outcome is Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01910298 |
| Phase | NA |
| Condition | Mastectomy and Breast Reconstruction |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 131 |
| Arms in the primary outcome | n/a |
| Lead sponsor | LifeCell |
| Results posted | Yes |
2. Clinical Question
Population
Female participants undergoing mastectomy and immediate post-mastectomy breast reconstruction. The primary outcome description refers to a post-ISS analysis set with a valid surgical assessment at least 337 days after the initial study surgery. It also describes results for unilateral and bilateral reconstruction. Other eligibility details are not reported in the registry record.
Intervention
Immediate direct-to-implant reconstruction with Strattice™ reconstructive tissue matrix. The initial study surgery was the direct-to-implant reconstruction with Strattice™ for participants in this group.
Comparator
Immediate two-stage reconstruction without reinforcement. The first surgery placed a tissue expander, which was inflated for approximately one to six months and then replaced with an implant.
Primary question
What was the mean number of planned and unplanned post-mastectomy surgical interventions on the reconstructed breast per participant within 12 months of the initial study surgery in each group? The registry record names this as the primary outcome but does not report its numerical group results.
The comparison concerns the number of subsequent surgical interventions after the initial reconstruction surgery, rather than a direct measure of a single clinical event. Planned and unplanned interventions are included together in the primary outcome, so the mean reflects both categories as recorded. The outcome description also distinguishes unilateral from bilateral reconstruction, but numerical results for either subgroup are not reported in the registry record.
3. Trial Design
The registry describes a prospective, multicenter, controlled study of immediate single-stage reconstruction with Strattice™ versus immediate two-stage reconstruction without reinforcement. Allocation was non-randomized, masking was none, and the model was parallel. These features matter when interpreting any group comparison: assignment was not determined by random allocation, and participants and study personnel were not masked according to the registry record. The record does not explain how treatment choice or assignment was made.
The listed enrollment was 131. The registry lists the study as terminated. Its recorded start date is 2013-07-29 and its primary completion date is 2016-08-31. The reason for termination is not reported in the registry record. The phase is listed as NA.
In the direct-to-implant group, participants underwent immediate reconstruction with a breast implant and Strattice™ reconstructive tissue matrix. In the two-stage group, participants had an initial tissue expander placement without reinforcement; the expander was inflated for approximately one to six months and later replaced with an implant. The primary outcome’s initial study surgery was defined as the direct-to-implant operation in the first group or the first surgery of the two-stage reconstruction in the second.
The comparison is not a randomized, like-for-like control comparison. Differences between groups could reflect factors related to treatment selection as well as any treatment-related differences. The registry record does not report adjustment methods that would address such differences, nor does it provide a detailed statistical analysis plan. Numerical primary outcome results, including group means and standard deviations, 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: Out of the 131 enrolled participants, 127 received the study device and were included in the Safety population.
Overall Study
| Stage | Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | Two Stage Breast Reconstruction |
|---|---|---|
| STARTED | 76 | 55 |
| Safety Set | 76 | 51 |
| COMPLETED | 71 | 23 |
| NOT COMPLETED | 5 | 32 |
Reasons for not completing this period:
| Reason | Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | Two Stage Breast Reconstruction |
|---|---|---|
| Adverse Event | 1 | 0 |
| Withdrawal by Subject | 2 | 7 |
| Protocol Deviation | 0 | 5 |
| Lost to Follow-up | 1 | 1 |
| Study Terminated by Sponsor | 1 | 17 |
| Other Miscellaneous Reasons | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: Post-ISS analysis set consisted of all participants who underwent a mastectomy and completed their first reconstruction surgery post-mastectomy and have a valid surgical assessment at least 337 days post ISS (12 month \[365 days\]-4 week \[28 days\] window). Number analyzed is the number of participants with data available at the given time-point.
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 set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded.
| Characteristic | Unit | Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | Two Stage Breast Reconstruction | Total |
|---|---|---|---|---|
| Participants analysed | 76 | 51 | 127 | |
| Age, Continuous | years | 46.8 (SD 10.58) | 49.5 (SD 10.40) | 47.9 (SD 10.56) |
| Sex: Female, Male: Female | Participants | 76 | 51 | 127 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Black/African American | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Caucasian | Participants | 51 | 35 | 86 |
| Race/Ethnicity, Customized: Other | Participants | 2 | 0 | 2 |
| Race/Ethnicity, Customized: Missing | Participants | 22 | 16 | 38 |
| Race/Ethnicity, Customized: Hispanic or Latino | Participants | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Non-Hispanic or non-Latino | Participants | 53 | 34 | 87 |
| Race/Ethnicity, Customized: Missing | Participants | 22 | 16 | 38 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS), measured over Up to 12 months post ISS.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | interventions per participant |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the mean number of planned and unplanned post-mastectomy surgical interventions on the reconstructed breast per participant, within 12 months of the initial study surgery. The record describes the measure as interventions per participant and identifies standard deviation as its dispersion measure. It states that the total number of planned and unplanned interventions was averaged within each group. The initial study surgery itself anchors the follow-up period and is defined differently according to the reconstruction approach.
This endpoint is used to describe the subsequent surgical burden over the stated follow-up period. Combining planned and unplanned interventions gives an overall count-based summary; it does not, by itself, distinguish the reasons for surgery, the clinical importance of each intervention, or whether an intervention was anticipated. The listed secondary outcomes separately include surgical interventions within six months of ISS and the number of such interventions without that six-month restriction.
Because the endpoint is a mean count, it summarizes the average number of interventions but may not describe how those counts are distributed among participants. A mean can be affected by participants with relatively many interventions, while participants with none or few may make up much of the group. The standard deviation describes variation in the observed counts, but neither the mean nor standard deviation is reported numerically in the registry record. Results are described as covering unilateral and bilateral reconstruction, but the corresponding estimates are not reported.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary outcome and its measurement window, but it does not report the numerical primary outcome results. No group means, standard deviations, effect estimate, confidence interval, or p-value for the mean number of surgical interventions appears in the registry record. Consequently, the size and precision of the primary comparison cannot be assessed from the registry record, and the direction of the observed primary outcome difference is not reported.
The design also limits what a group comparison could establish. Allocation was non-randomized and masking was none. In general, non-random allocation can leave groups different in characteristics that influence both treatment selection and outcomes. Without information about treatment assignment and any adjustment for group differences, a numerical contrast would not automatically represent an effect attributable to the reconstruction approach. The registry record does not report an adjusted primary comparison or details of an adjustment strategy.
The primary endpoint is a mean number of interventions during a defined period. It includes planned as well as unplanned procedures, so its interpretation depends on which procedures were counted and how they were classified. The record describes the broad measure but does not report the specific intervention-level data or numerical group summaries. It also describes a post-ISS analysis set requiring a valid surgical assessment at least 337 days after ISS. The number included in that analysis set is not reported in the registry record.
Other posted outcome information concerns complications, capsular contracture, aesthetic assessment, and surgical interventions at additional time windows. The record lists these secondary outcomes but does not provide their numerical results in the registry record for this analysis. The adverse-event information reports group counts for participants at risk and affected, along with serious adverse-event terms and percentages; those figures are not a substitute for the missing primary endpoint results.
The study is listed as terminated, but the reason is not reported in the registry record. Termination alone does not establish why recruitment or follow-up stopped, whether the planned analysis was completed, or whether the outcome findings favored either group. The enrollment entry does not establish the number analyzed for the primary endpoint. With no primary effect estimate or uncertainty interval reported, a statistical conclusion about the comparative mean intervention count cannot be drawn from the registry record.
9. Statistical Methods Explained
The registry record identifies a continuous primary measure summarized as a mean with standard deviation. The endpoint is a count of planned and unplanned post-mastectomy interventions per participant, averaged within each group. The record does not report the numerical means, standard deviations, or a formal comparison for this outcome. The explanations below describe general statistical concepts and the assumptions listed for planning illustrations, not an unreported analysis performed by the study.
What does the mean describe?
In general, a mean is the arithmetic average of observed values in a group. For a count outcome, each participant contributes a count of interventions over the specified observation period, and the mean gives an average count per participant. It is a compact summary, but does not show whether counts are similar across participants or concentrated among a smaller number of participants. The standard deviation describes the spread of observations around the mean. It is not a confidence interval and does not, by itself, quantify the precision of a group mean.
Here, the outcome combines planned and unplanned procedures. Those categories may represent different clinical circumstances, so a combined mean does not reveal their separate contributions. The description also says that data are presented for unilateral and bilateral reconstruction. Separate results would be needed to examine those groups; such numerical results are not reported in the registry record.
Why does allocation matter?
In general, random allocation helps make treatment groups comparable with respect to measured and unmeasured characteristics, on average. In a non-randomized study, treatment selection may be related to participant characteristics, clinical circumstances, or other factors that also relate to outcomes. This creates potential confounding. A difference in observed group means can therefore reflect both treatment-group differences and differences in the people who received each approach. The record identifies non-randomized allocation but does not report the assignment process, baseline comparability, or a statistical adjustment plan.
Masking is listed as none. In general, knowledge of treatment assignment can influence care decisions or outcome assessment, depending on the outcome and how it is recorded. The primary outcome counts surgical interventions, and the registry description does not provide details about how interventions were adjudicated or whether planned and unplanned status was determined using prespecified criteria.
How should uncertainty be understood?
In general, a confidence interval gives a range of values compatible with the data under the model used to calculate it. Its width reflects statistical precision: a narrower interval indicates greater precision under that model, while a wider interval indicates less. A p-value addresses compatibility between observed data and a specified null hypothesis under modeling assumptions; it is not a measure of clinical importance or the probability that a treatment effect is true. Neither a confidence interval nor a p-value for the primary comparison is reported in the registry record.
Count data can have features that complicate analysis. In general, counts may be skewed, and their variability can exceed what a simple model assumes. Over-dispersion means that variation is greater than expected under a particular count model; if not accounted for, standard errors and uncertainty estimates can be unreliable. This is a general consideration for count outcomes, not a claim that over-dispersion was observed in this trial. The registry record does not report the model used for the primary count outcome or how its distribution was assessed.
What do the planning assumptions mean?
The record describes sample-size planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The planning effect is described as a stated fraction of the observed effect. These are planning assumptions, not evidence about the study’s actual statistical analysis plan. Sample-size illustrations are prospective planning quantities; they are not observed power and do not establish that a study was adequately powered. The numerical planning results and the observed effect used for them are not reported in the registry record.
The record further notes that time-to-event planning tables use total events, while other planning tables use participants per arm. The primary outcome is a mean count, not a time-to-event endpoint. The registry record does not report whether those planning illustrations match the final analysis population, the actual allocation, or the eventual outcome data.
What analysis details are absent?
The registry lists 10 outcome measures and zero analyses. The primary outcome’s population description states that the post-ISS analysis set includes participants who underwent mastectomy, completed their first reconstruction surgery, and had a valid surgical assessment at least 337 days post ISS. It then describes the number analyzed, but the numerical analysis-set size is not reported in the registry record. Further details about missing observations, handling of incomplete follow-up, exclusions, model specification, covariate adjustment, and sensitivity analyses are not reported in the registry record. These gaps prevent independent assessment of the primary analysis’s assumptions and robustness.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures, including a primary outcome and several secondary outcomes related to serious breast reconstruction-related complications, complications within 24 months of post-permanent reconstruction, capsular contracture, aesthetic assessment, and surgical interventions at additional time windows. Considering multiple outcomes can increase the chance of finding an apparently notable result by chance. In general, multiplicity is addressed by prespecifying which outcomes are primary and, when appropriate, adjusting interpretation or testing procedures for multiple comparisons. The registry record does not report a multiplicity strategy, such as a testing hierarchy or adjustment method.
The record lists zero analyses. Numerical results for the primary and secondary outcomes are not reported in the registry record in the registry record for this analysis. It is therefore not possible to assess the number of comparisons actually conducted, whether outcome definitions changed, or whether any multiplicity approach was applied.
The primary analysis population is described as participants who underwent mastectomy, completed their first reconstruction surgery, and had a valid surgical assessment at least 337 days after ISS. The description gives the required assessment window, but the number analyzed is not reported. The registry record does not report how missing surgical assessments, withdrawals, or other incomplete observations were handled, nor whether the analysis followed an intention-to-treat, per-protocol, or other population definition. These details matter because exclusion from a follow-up analysis can affect how representative the analyzed participants are of those enrolled.
The enrolled number is 131, but it should not be treated as the number analyzed for the primary outcome. The analysis-set size and reasons for any differences between enrollment and analysis are not reported in the registry record. The reason for termination is also not reported, so its relationship, if any, to missing outcome information cannot be determined.
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 |
|---|---|---|---|
| Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | 49 | 76 | 64.5% |
| Two Stage Breast Reconstruction | 27 | 51 | 52.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | 0 of 76 |
| Two Stage Breast Reconstruction | 0 of 55 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | 53 of 76 |
| Two Stage Breast Reconstruction | 35 of 51 |
Most frequent serious adverse event terms
| Event term | Organ system | Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | Two Stage Breast Reconstruction |
|---|---|---|---|
| Breast reconstruction | Surgical and medical procedures | 12 of 76 | 1 of 51 |
| Fat tissue decreased | General disorders | 5 of 76 | 4 of 51 |
| Mastitis | Infections and infestations | 7 of 76 | 2 of 51 |
| Anisomastia | Reproductive system and breast disorders | 5 of 76 | 3 of 51 |
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 4 of 76 | 1 of 51 |
| Postoperative wound complication | Injury, poisoning and procedural complications | 5 of 76 | 0 of 51 |
| Capsular contracture associated with breast implant | Reproductive system and breast disorders | 2 of 76 | 2 of 51 |
| Device extrusion | Product Issues | 3 of 76 | 1 of 51 |
| Device dislocation | Product Issues | 1 of 76 | 3 of 51 |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | 2 of 76 | 2 of 51 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | Two Stage Breast Reconstruction |
|---|---|---|---|
| Seroma | Injury, poisoning and procedural complications | 26 of 76 | 13 of 51 |
| Erythema | Skin and subcutaneous tissue disorders | 10 of 76 | 8 of 51 |
| Post procedural haematoma | Injury, poisoning and procedural complications | 5 of 76 | 13 of 51 |
| Procedural pain | Injury, poisoning and procedural complications | 6 of 76 | 12 of 51 |
| Breast pain | Reproductive system and breast disorders | 4 of 76 | 6 of 51 |
| Nausea | Gastrointestinal disorders | 4 of 76 | 6 of 51 |
| Hot flush | Vascular disorders | 4 of 76 | 5 of 51 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 4 of 76 | 4 of 51 |
| Capsular contracture associated with breast implant | Reproductive system and breast disorders | 4 of 76 | 3 of 51 |
| Mastitis | Infections and infestations | 6 of 76 | 1 of 51 |
Serious events with the highest arm-level rate: breast reconstruction (15.8%), mastitis (9.2%), fat tissue decreased (7.8%), anisomastia (6.6%), postoperative wound complication (6.6%).
The registry reports serious and other adverse-event figures separately for the two reconstruction groups. For direct-to-implant reconstruction with Strattice™, 76 participants are listed as at risk for serious events and 49 as affected; for two-stage reconstruction, 51 are listed as at risk and 27 as affected. For other adverse events, the corresponding at-risk and affected counts are 76 and 53 in the direct-to-implant group, and 51 and 35 in the two-stage group. The registry lists deaths as 0 in each group.
These are descriptive counts, not a randomized comparison. Because allocation was non-randomized, differences between groups should not be interpreted as effects of the procedures without considering potential group differences. No comparative safety estimate or uncertainty interval is reported in the registry record. The at-risk counts also differ by group, so the affected counts should be read with their reported group denominators rather than compared as if the groups had equal size.
The listed serious-event terms include Breast reconstruction (15.8%), Mastitis (9.2%), Fat tissue decreased (7.8%), Anisomastia (6.6%), Postoperative wound complication (6.6%), and Device dislocation (5.9%). The denominator and calculation basis for these percentages are not reported in the registry record, so they should not be treated as group-specific rates or as mutually exclusive categories. These safety summaries do not provide the missing primary outcome results.
12. What the Result Does, and Does Not, Mean
The registry record establishes the question the study set out to examine: whether immediate direct-to-implant reconstruction with Strattice™ and immediate two-stage reconstruction without reinforcement differed in the mean number of planned and unplanned post-mastectomy surgical interventions per participant within 12 months of the initial study surgery. It also describes the two surgical approaches and the endpoint’s timing and analysis population.
However, the registry record does not report the numerical primary outcome results. There is no reported group mean, standard deviation, comparative estimate, confidence interval, or p-value for the primary outcome. The available record therefore does not show whether the observed average intervention count was higher or lower in either group, or how precisely any difference was estimated. No conclusion about the comparative primary outcome can be drawn from these registry entries.
Even if a group contrast were available, the design would need to shape its interpretation. This was a non-randomized study with no masking. In general, group differences may arise from factors associated with treatment selection, and the record does not report an adjustment approach that would address such differences. An observed association would not automatically establish that the reconstruction approach caused the difference.
The endpoint combines planned and unplanned interventions, and the record does not give the details needed to separate those components or assess their individual importance. The listed safety counts and serious-event terms offer descriptive information, but do not replace the primary endpoint analysis or establish a comparative safety effect. The listed enrollment is not the same as a reported primary analysis population; the number analyzed is not reported.
The study’s terminated status and its recorded dates describe the registry record, but the reason for termination is not reported. That status alone does not indicate the direction or quality of the results. Overall, the registry record documents a comparative study question and selected safety counts, but not the numerical primary findings needed to assess the outcome’s magnitude or precision.
13. Why This Trial Matters Statistically
This trial raises statistical issues common to studies that compare surgical approaches. Its primary outcome is a participant-level mean count over a defined period, which can describe average intervention burden but may conceal how unevenly interventions are distributed. Combining planned and unplanned interventions can also make the average harder to interpret clinically unless the components and their reasons are reported separately.
The non-randomized allocation is especially important. In general, treatment choice in a non-randomized study can be related to participant or clinical characteristics that also influence later outcomes. This can make an unadjusted group contrast difficult to interpret as a treatment effect. The registry record does not report how assignment occurred, what baseline characteristics were measured, or whether an adjusted analysis was planned or performed.
Follow-up and analysis-population definitions also matter. The primary outcome description requires a valid assessment at least 337 days after the initial study surgery. Such a requirement identifies the stated assessment window, but interpretation also depends on how many participants met it and how missing assessments were handled. Neither the analysis-set size nor missing-data procedures are reported in the registry record.
Finally, the record lists multiple outcome measures but does not report a multiplicity strategy or numerical primary results. Without an effect estimate and its uncertainty, readers cannot judge the primary comparison’s magnitude or precision. The case illustrates why registry outcome definitions, analysis populations, missing-data handling, and numerical estimates are all needed for a complete statistical interpretation of a clinical comparison.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation of the available record is that it does not report numerical results for the primary outcome. Group means and standard deviations are absent, as are a between-group estimate, confidence interval, and p-value. The registry record therefore does not permit assessment of the primary endpoint’s observed direction, magnitude, or precision.
The allocation was non-randomized and masking was none. The record does not describe the assignment process, baseline characteristics, or any adjustment for potential differences between groups. Consequently, even a reported crude contrast would require caution, and the registry entries do not establish a causal comparison.
The primary outcome population description specifies a valid surgical assessment at least 337 days after ISS, but the number analyzed is not reported. The record does not report missing-data methods, reasons for exclusions, or sensitivity analyses. It also does not report detailed rules for classifying and counting planned and unplanned procedures, or numerical results separately for unilateral and bilateral reconstruction.
Although 10 outcome measures are listed, the registry record does not report a multiplicity strategy or numerical results for the listed secondary outcomes. The adverse-event section provides counts and selected terms, but the denominator basis for the listed term percentages is not reported. The study is listed as terminated, but the reason is not reported in the registry record. These omissions limit interpretation of both effectiveness and safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy — NCT01910298.
- Registry record last updated 2019-12-04; status last verified 2019-04.
- Results first posted 2019-12-04.
- 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 registry describes a prospective, multicenter, controlled, parallel study comparing immediate direct-to-implant breast reconstruction with Strattice™ against immediate two-stage reconstruction without reinforcement. Allocation was non-randomized and masking was none. Enrollment is listed as 131, and study status is terminated; the reason for termination is not reported in the registry record.
The primary outcome was the mean number of planned and unplanned post-mastectomy surgical interventions per participant within 12 months of the initial study surgery. The record describes a post-ISS analysis population requiring a valid assessment at least 337 days after ISS, but does not report the number analyzed or the numerical primary results. It lists 10 outcome measures and zero analyses.
Descriptive adverse-event counts and selected serious-event terms are reported, but no comparative safety estimate is given. The non-randomized design and missing primary outcome results prevent assessment of the comparative intervention-count finding from the registry record.