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 Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure) (NCT03342690), a registered phase not stated study. The primary outcome is Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03342690 |
| Phase | Phase not stated |
| Condition | Chronic Heart Failure |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 1165 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| Results posted | Yes |
2. Clinical Question
The clinical question concerns the safety of Selara (eplerenone) under Japanese medical practice among people with chronic heart failure. In particular, the primary endpoint asks what percentage of participants with moderate renal impairment had an adverse drug reaction attributed to Selara during the stated follow-up period. The registry defines moderate renal impairment as eCLCr at least 30 mL/min and below 50 mL/min.
Population
People with chronic heart failure receiving Selara in routine Japanese medical practice. The primary endpoint focuses on the subgroup with moderate renal impairment. The safety analysis set included 1139 participants, of whom 316 were described as having moderate renal impairment.
Intervention
Selara tablets, identified as eplerenone. The record describes a secondary data collection study of its safety and effectiveness in medical practice, rather than a comparison of assigned treatments.
Comparator
No like-for-like control group is described. The record identifies an eplerenone group, and allocation is not stated. The posted data therefore do not support a randomized between-group treatment comparison.
Primary question
Among chronic heart failure participants with moderate renal impairment who received Selara, what percentage had an adverse drug reaction attributed to the drug during the 52 weeks from the start date? The registry record defines how an adverse drug reaction was judged, but does not report the numerical result for this subgroup endpoint.
The record lists 1165 participants as the enrollment and describes a safety population of 1139. Those figures refer to different recorded populations; the registry does not explain the complete flow between them. The key interpretive issue is that the named primary question is narrower than the overall safety summaries: the endpoint concerns participants with moderate renal impairment, whereas the aggregate adverse-reaction counts are reported for the broader safety set.
3. Trial Design
This is a completed drug use investigation and secondary data collection study of Selara tablets (eplerenone) for chronic heart failure. Its stated purpose is to collect information about safety and effectiveness under Japanese medical practice. The record lists an enrollment of 1165 and identifies one intervention, eplerenone. It describes patients with chronic heart failure receiving Selara; it does not describe a randomized allocation or a separate control treatment. Allocation is not stated, and the record warns that the listed arms are not a like-for-like control comparison.
The study start date is 2017-07-05, the primary completion date is 2020-07-15, and the status is completed. These dates describe the study record, not the individual follow-up period for every participant. The primary endpoint timeframe is stated as 52 weeks from the start date. The registry record does not report further details about participant-level follow-up schedules, recruitment procedures, or how observations were collected and verified.
The primary safety population is described as chronic heart failure participants who met the inclusion criteria and received Selara at least once. It comprised 1139 participants. Within that set, 316 participants were reported as having moderate renal impairment, defined using eCLCr. The primary endpoint concerns adverse drug reactions in that subgroup, while the aggregate safety counts describe the broader safety set.
The listed outcomes include the primary adverse-reaction measure and secondary measures concerning adverse drug reactions and mortality. The registry record does not report a randomized comparison, a comparator arm, or a statistical analysis record. Accordingly, the design is best read as observational safety and effectiveness data collection in clinical practice, not as evidence from a controlled efficacy trial. The registry does not report a protocol-level explanation of the enrollment target or the methods used to address differences among participants.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Selara Tablets (Eplerenone) |
|---|---|
| STARTED | 1164 |
| COMPLETED | 1139 |
| NOT COMPLETED | 25 |
Reasons for not completing this period:
| Reason | Selara Tablets (Eplerenone) |
|---|---|
| Missing Information | 9 |
| Protocol Violation | 16 |
Analysis population for the primary outcome, as defined in the registry: The safety analysis set comprised of chronic heart failure participants who satisfied the inclusion criteria and had received Selara at least once. Of the participants included in the safety analysis set (n=1139), 316 participants had moderate renal impairment (≥30 mL/min and \<50 mL/min in eCLCr).
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: A total of 1165 participants were enrolled in this study. Of the 1164 participants who completed the study, 25 participants were excluded from the safety analysis set due to the following reasons: protocol violation (16 participants), and no adverse event information (no visit after first day of treatment or unknown) (9 participants).
| Characteristic | Unit | Selara Tablets (Eplerenone) |
|---|---|---|
| Participants analysed | 1139 | |
| Age, Customized: <15 years | Participants | 0 |
| Age, Customized: ≥15 and <65 years | Participants | 219 |
| Age, Customized: ≥65 years | Participants | 920 |
| Sex: Female, Male: Female | Participants | 516 |
| Sex: Female, Male: Male | Participants | 623 |
| Race and Ethnicity Not Collected | Participants | — |
| Estimated creatinine clearance (eCLCr): <30 mL/min | Participants | 92 |
| Estimated creatinine clearance (eCLCr): ≥30 mL/min and <50 mL/min | Participants | 316 |
| Estimated creatinine clearance (eCLCr): ≥50 mL/min | Participants | 524 |
| Estimated creatinine clearance (eCLCr): Unknown | Participants | 207 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment, measured over 52 weeks from the start date.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with adverse drug reactions among chronic heart failure participants with moderate renal impairment who received Selara. The timeframe is 52 weeks from the start date. The registry defines an adverse drug reaction as an untoward medical occurrence attributed to Selara. A serious adverse drug reaction is one resulting in specified serious outcomes, or one considered significant for another reason. The listed outcomes include death, a life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability or incapacity, and congenital anomaly. The physician assessed relatedness to Selara.
A percentage endpoint expresses how common the recorded event was in the defined population; it is different from a count of events because its interpretation depends on the population denominator. For this endpoint, the relevant population is the moderate renal impairment subgroup, not the entire safety set. The record states that 316 participants in the safety analysis set had moderate renal impairment, but it does not report the subgroup’s adverse-reaction count or percentage. Thus, the endpoint’s definition is available, but its numerical result cannot be interpreted from the registry record.
Safety endpoints of this kind are used to describe observed reactions and to monitor events that clinicians judge to be related to treatment. They do not, by themselves, establish that treatment caused an event. In a nonrandomized medical-practice investigation, participants’ health status, coexisting conditions, and care may also be relevant to observed outcomes. The registry record does not report an adjustment strategy for these factors.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record’s central statistical question is specific: it concerns the percentage of chronic heart failure participants with moderate renal impairment who had an adverse drug reaction attributed to Selara. Although the subgroup size is reported as 316, the registry record does not report the subgroup event count, percentage, or confidence interval. No numerical conclusion about the primary endpoint’s magnitude or precision can therefore be drawn from the record.
Separate aggregate safety counts are reported for the broader safety analysis set of 1139 participants. The posted counts are 103 in the serious category and 121 in the other adverse-reaction category. These are counts, not percentages, and the registry record does not establish that the categories are mutually exclusive. They should not be added together or treated as a single event total. Nor do these aggregate counts answer the primary subgroup question: they refer to the broader safety set, not specifically to participants with moderate renal impairment.
The serious-reaction terms listed include Cardiac failure at 1.3%, Pneumonia at 0.7%, Cardiac failure acute at 0.6%, Cardiac failure chronic at 0.5%, Cardiac failure congestive at 0.4%, and Cerebral infarction at 0.4%. These are registry-listed percentages for terms categorized as serious. The registry record does not give the denominator or further calculation details for these term percentages. The percentages should therefore be read as reported descriptive summaries, not as risks that can be compared across terms or populations without additional information.
The study is described as a secondary data collection investigation in Japanese medical practice. There is no reported randomized comparator, and allocation is not stated. As a general statistical point, observations from a single treatment group can describe events occurring during treatment, but cannot separate treatment effects from underlying illness, other care, or participant characteristics. The record’s own warning that the arms are not a like-for-like control comparison reinforces that limitation.
The registry lists an enrollment of 1165, a safety analysis set of 1139, and 316 participants with moderate renal impairment. These numbers describe the recorded enrollment and analysis populations; they do not by themselves explain why participants were not included in the safety set or whether all participants contributed complete follow-up. Details of exclusions, missing outcome data, and follow-up completeness are not reported in the registry record.
The listed secondary outcomes concern adverse drug reactions and mortality, including overall and cardiovascular deaths and mortality rates. However, the registry record reports no analysis records. Numerical results, uncertainty estimates, and methods for those secondary outcomes are therefore not available in the record. The completed status indicates that the study record is marked completed; it does not establish that every planned outcome was measured or reported.
Overall, the posted information supports a description of the study’s purpose, population definitions, endpoint rules, and selected aggregate safety summaries. It does not provide the primary subgroup result or enough analysis detail to quantify its precision, assess adjusted associations, or make a causal treatment comparison.
9. Statistical Methods Explained
Percentages, counts, and comparisons answer different questions. A count reports how many events were recorded; a percentage relates events to a defined population. For an event percentage to be interpretable, the event count and denominator must refer to the same population and follow-up definition. The registry gives a safety analysis set of 1139 participants and identifies 316 with moderate renal impairment, but does not give the primary endpoint event count or percentage within that subgroup. The aggregate counts cannot be substituted for that missing subgroup result.
What does a percentage endpoint describe?
In general, a percentage of participants with an event describes the proportion of a defined group for whom at least one qualifying event was recorded during a stated observation period. The registry’s primary endpoint uses this kind of measure. It specifies the subgroup, event definition, and timeframe, but a numerical estimate requires the subgroup’s observed event information. Without that estimate, it is not possible to judge the observed frequency from the primary endpoint itself.
Event percentages also depend on how an event is defined and attributed. Here, the registry defines an adverse drug reaction as an untoward medical occurrence attributed to Selara, with relatedness assessed by a physician. This is not the same as recording every medical event regardless of attribution. Attribution is a clinical judgment, and the record does not report whether independent review or a standardized adjudication process was used.
Why does the analysis population matter?
The safety analysis set is defined as chronic heart failure participants who met inclusion criteria and received Selara at least once. This definition identifies the population used for the safety summaries. The primary endpoint then narrows attention to participants with moderate renal impairment within that set. Analyses using the whole safety set and analyses using the renal impairment subgroup address different populations and should not be treated as interchangeable.
In general, analysis populations can differ from enrollment populations because eligibility, exposure, or availability of outcome information may affect inclusion. The record reports enrollment of 1165 and a safety set of 1139, but does not report a participant flow explanation that accounts for the difference. It also does not report a separate analysis population for effectiveness outcomes. The reasons for inclusion or exclusion beyond the stated safety-set definition are not reported in the registry record.
How should uncertainty be considered?
A confidence interval is a general statistical tool for expressing uncertainty around an estimated quantity. It indicates a range of values compatible with the data under the assumptions of the method; it is not a guarantee that the true value lies within that range. The registry record does not report a confidence interval for the primary endpoint, nor does it provide the subgroup result from which an interval could be interpreted. Precision therefore cannot be assessed for the primary endpoint from the available registry information.
More generally, uncertainty in an observed percentage depends on the number of participants and events, and on the way data were collected and analyzed. A larger analysis population does not remove possible bias from incomplete follow-up, event misclassification, or selective reporting. The record does not report details needed to assess those issues, including missing-data handling, censoring rules, or sensitivity analyses.
What does a nonrandomized design imply?
As a general statistical principle, random assignment can help balance measured and unmeasured participant characteristics across treatment groups. This record does not describe randomization or a comparable untreated or alternative-treatment group. It is a drug use investigation in medical practice, and allocation is not stated. Consequently, descriptive event summaries can characterize what was recorded among Selara recipients, but cannot isolate a causal effect of Selara from other influences.
Confounding is a general concern when treatment exposure is not assigned randomly. Factors related both to treatment and to outcomes can make an observed association differ from a treatment effect. The registry record does not report an adjusted analysis or identify a statistical model for addressing confounding. The record also explicitly notes that the arms are not a like-for-like control comparison, so a between-arm contrast should not be interpreted as a controlled estimate.
What can planning calculations tell readers?
Sample-size calculations are planning illustrations, not observed outcomes. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. The record cautions that such calculations are not the study’s own design. For time-to-event calculations, the stated output is a total number of events; for other calculations, it is participants per arm.
As a general explanation, a planning calculation explores how much information a future study might need under chosen assumptions. Its output does not indicate the probability that the completed study found a true effect, and it is not observed power. The registry record does not report that these assumptions were part of the original protocol or sample-size justification. The record also does not report an observed primary subgroup effect from which a reader could assess the practical meaning of an effect-based planning illustration.
Finally, the registry lists six outcome measures and no analysis records. The absence of analysis records means that the registry record does not provide model specifications, confidence intervals, hypothesis tests, or a detailed statistical analysis plan. It is therefore appropriate to distinguish the endpoint definitions and descriptive counts that are recorded from inferential conclusions that would require reported analyses.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures. The named primary outcome concerns the percentage of participants with adverse drug reactions among chronic heart failure participants with moderate renal impairment. The secondary outcomes cover adverse drug reactions and mortality, including overall deaths, cardiovascular deaths, and mortality rates. Considering several outcomes can raise a multiplicity issue: in general, when many hypotheses are tested, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for the number and relationship of tests.
The registry record does not report a multiplicity strategy, hierarchy of secondary hypotheses, or adjustment method. It also reports no analysis records, so it does not provide hypothesis-test results or information about which outcomes were analyzed. No claim about statistical significance or multiplicity-adjusted inference can be made from the record.
Missing-data methods are also not reported in the registry record. There is no stated approach for incomplete outcome information, loss to follow-up, or participants whose follow-up did not cover the full stated timeframe. The enrollment of 1165 and safety analysis set of 1139 are both reported, but the record does not explain the participant flow between those populations. It would be inappropriate to infer reasons for the difference or assume that missing outcomes were absent.
The safety population is defined by meeting inclusion criteria and receiving Selara at least once. The moderate renal impairment subgroup is identified within that set. The record does not provide further details about the analysis population for mortality outcomes, how follow-up time was handled, or whether all listed outcomes used the same participants. Such information is important when interpreting rates and comparing results across 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 |
|---|---|---|---|
| Selara Tablets (Eplerenone) | 103 | 1139 | 9.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Selara Tablets (Eplerenone) | 44 of 1139 |
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 |
|---|---|
| Selara Tablets (Eplerenone) | 121 of 1139 |
Most frequent serious adverse event terms
| Event term | Organ system | Selara Tablets (Eplerenone) |
|---|---|---|
| Cardiac failure | Cardiac disorders | 15 of 1139 |
| Pneumonia | Infections and infestations | 8 of 1139 |
| Cardiac failure acute | Cardiac disorders | 7 of 1139 |
| Cardiac failure chronic | Cardiac disorders | 6 of 1139 |
| Cardiac failure congestive | Cardiac disorders | 5 of 1139 |
| Cerebral infarction | Nervous system disorders | 4 of 1139 |
| Ventricular fibrillation | Cardiac disorders | 3 of 1139 |
| Sinus node dysfunction | Cardiac disorders | 3 of 1139 |
| Hyperkalaemia | Metabolism and nutrition disorders | 3 of 1139 |
| Dehydration | Metabolism and nutrition disorders | 3 of 1139 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Selara Tablets (Eplerenone) |
|---|---|---|
| Renal impairment | Renal and urinary disorders | 24 of 1139 |
| Hyperkalaemia | Metabolism and nutrition disorders | 16 of 1139 |
| Hypotension | Vascular disorders | 10 of 1139 |
| Blood pressure decreased | Investigations | 9 of 1139 |
| Dehydration | Metabolism and nutrition disorders | 5 of 1139 |
| Cardiac failure | Cardiac disorders | 4 of 1139 |
| Blood potassium increased | Investigations | 4 of 1139 |
| Anaemia | Blood and lymphatic system disorders | 3 of 1139 |
| Oedema | General disorders | 3 of 1139 |
| Hypokalaemia | Metabolism and nutrition disorders | 3 of 1139 |
Serious events with the highest arm-level rate: cardiac failure (1.3%), pneumonia (0.7%), cardiac failure acute (0.6%), cardiac failure chronic (0.5%), cardiac failure congestive (0.4%).
The registry reports 103 participants in the serious adverse-reaction category and 121 in the other adverse-reaction category, each against a stated safety-set size of 1139. These are posted category counts. The record does not state that the categories are mutually exclusive, so the counts should not be combined to produce a total. They are also not percentages and should not be read as the primary endpoint result for the moderate renal impairment subgroup.
The listed serious terms and percentages are Cardiac failure at 1.3%, Pneumonia at 0.7%, Cardiac failure acute at 0.6%, Cardiac failure chronic at 0.5%, Cardiac failure congestive at 0.4%, and Cerebral infarction at 0.4%. The registry record does not specify the denominator or calculation details for these term percentages. They are best treated as descriptive figures recorded for the serious category, rather than comparative estimates.
The endpoint definition says that relatedness to Selara was assessed by the physician. An adverse drug reaction is therefore an event attributed to the drug, not simply every event that occurred during follow-up. The registry does not report an independent adjudication process or comparative background event rates. These figures describe recorded safety information; they do not, by themselves, establish causation or quantify a difference from another treatment.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed secondary data collection study examined Selara (eplerenone) in chronic heart failure under Japanese medical practice. It defines a primary safety endpoint focused on participants with moderate renal impairment, states a 52-week timeframe, and describes how adverse drug reactions and serious reactions were classified. It also gives the size of the safety analysis set and the size of the renal impairment subgroup.
What the record does not provide is the numerical result for the primary endpoint. Although 316 participants are reported in the subgroup, no corresponding adverse-reaction count, percentage, or confidence interval is stated. The broader safety counts and serious-term percentages do not fill this gap because they refer to aggregate safety information and do not report the primary subgroup estimate.
The aggregate safety figures can be read as descriptive records of reactions among Selara recipients. They do not show what would have happened to comparable participants under a different treatment or without Selara. In general, treatment attribution is difficult to isolate in an observational study because the underlying illness and other aspects of care can also relate to outcomes. This record does not describe a randomized comparator or adjusted analysis.
The record lists mortality outcomes as secondary measures, but it does not provide their numerical results or analysis details. It also does not report missing-data methods, confidence intervals, or a multiplicity approach. As a result, it is not possible to assess precision, completeness of follow-up, or inferential uncertainty for those outcomes from the registry record.
The appropriate conclusion is limited to the information recorded: a routine-practice investigation collected safety and effectiveness data, and the registry describes its endpoint definitions and selected aggregate safety summaries. It does not establish a treatment effect, comparative safety, or a numerical primary endpoint result. Those questions require reported analyses and enough information to evaluate their populations, methods, and uncertainty.
13. Why This Trial Matters Statistically
This investigation is statistically relevant because it addresses safety information collected during Japanese medical practice rather than only under a randomized treatment assignment. Such data can describe the kinds of events recorded among people receiving a drug in clinical care. The record’s focus on chronic heart failure and moderate renal impairment also makes the definition of the analysis population especially important: the primary endpoint applies to a subgroup, while the posted aggregate safety counts apply to a broader set.
The distinction between a subgroup endpoint and an overall safety summary is a basic but consequential interpretive issue. A subgroup’s event percentage cannot be inferred from counts for the full safety set. Likewise, a count without a clearly stated event denominator and analysis context does not answer a question about comparative risk. The record states the subgroup size but not its primary event result, so its central safety estimate remains unavailable in the registry record.
The record also illustrates why design labels matter. A secondary data collection study can provide descriptive information, but without a like-for-like control group it cannot establish whether observed events are more or less frequent because of treatment. The registry explicitly warns that the arms are not a like-for-like control comparison and does not state allocation. Clear reporting of these features prevents descriptive results from being mistaken for causal estimates.
Finally, the listed mortality outcomes and adverse-reaction measures span different kinds of endpoints. Counts, percentages, and mortality rates have distinct denominators and interpretations. Since no analysis records are reported, readers cannot evaluate the statistical methods, precision, or handling of multiple outcomes. The record is therefore useful for understanding the study’s questions and data definitions, while also showing why complete outcome reporting and transparent analysis methods are essential for interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation for interpreting the main safety question is that the registry record does not report the moderate renal impairment subgroup’s adverse-reaction result. It gives the subgroup size of 316 but not the event count, percentage, or uncertainty interval. The broader counts of 103 in the serious category and 121 in the other category concern the safety analysis set and cannot substitute for the subgroup endpoint.
The study is described as a secondary data collection investigation in clinical practice, not a randomized comparison. Allocation is not stated, and the record says the arms are not a like-for-like control comparison. Therefore, the information does not support a controlled estimate of treatment effect. The registry record does not report adjusted analyses that might address differences among participants.
Additional details that would help assess the data are not reported in the registry record. These include reasons for the difference between enrollment of 1165 and the safety analysis set of 1139, participant-level follow-up completeness, missing-data procedures, and the denominator details for serious-term percentages. The record also does not report the statistical analysis plan, multiplicity handling, confidence intervals, or analysis methods for the listed mortality outcomes.
The endpoint relies on physician assessment of whether an event was related to Selara. The record does not describe independent adjudication or additional safeguards against differences in attribution. The listed adverse-reaction counts and percentages should consequently be interpreted as recorded clinical assessments, not as proof that treatment caused the events. These limitations constrain both the precision of the safety conclusions and the comparisons that can be drawn from the posted information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure) — NCT03342690.
- Registry record last updated 2023-07-11; status last verified 2023-06.
- Results first posted 2021-06-28.
- 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 record describes a completed secondary data collection study of Selara (eplerenone) for chronic heart failure under Japanese medical practice. Enrollment is listed as 1165. The safety analysis set comprised 1139 participants, including 316 with moderate renal impairment. The primary endpoint is the percentage of participants with adverse drug reactions in that subgroup over 52 weeks from the start date.
The registry reports aggregate adverse-reaction category counts of 103 and 121 for the safety set, along with serious-term percentages. It does not report the numerical result for the primary subgroup endpoint. The record lists mortality and other safety outcomes, but reports no analysis records. Allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison.