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 Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy (NCT02891850), a randomized phase 4 study. The primary outcome is Number of Participants With Satisfactory Clinical Response at Week 24.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02891850 |
| Phase | Phase 4 |
| Condition | Pulmonary Arterial Hypertension |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 225 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bayer |
| Results posted | Yes |
2. Clinical Question
Population
Patients with pulmonary arterial hypertension who were receiving a stable dose of a phosphodiesterase-5 inhibitor, with or without an endothelin receptor antagonist, and were not at treatment goal.
Intervention
Stopping PDE-5 inhibitor treatment and beginning riociguat after a defined washout period, followed by dose adjustment.
Comparator
Continuing PDE-5 inhibitor treatment, with other standard-of-care treatments left to the investigator's discretion.
Primary question
At Week 24, how many participants in each group met the registry's definition of satisfactory clinical response?
The comparison concerns a treatment strategy: replacing an existing PDE-5 inhibitor with riociguat versus continuing PDE-5 inhibitor therapy. The registry describes sildenafil and tadalafil as interventions and identifies riociguat as the replacement treatment. The primary outcome is not a single measurement such as walking distance. It classifies a participant as having a satisfactory response if at least two of three specified clinical criteria are met at Week 24.
The endpoint combines change in 6 Minute Walking Distance, functional class, and NT-proBNP response. For the biomarker criterion, the record also requires absence of defined clinical worsening. This composite gives the clinical question a broader scope than a question about any one measure alone: participants can meet the response definition through different combinations of the criteria.
The registry record does not report the number meeting the primary endpoint in either arm, nor a between-group estimate or uncertainty interval. Therefore, the record describes the question and its measurement but does not establish how the groups compared on the primary endpoint.
3. Trial Design
This was a Phase 4, randomized, parallel-group, open-label study. The record describes it as prospective, international, multicenter, and controlled. Enrollment was 225. The study is listed as completed; its recorded start date is 2017-01-11 and its primary completion date is 2020-01-29.
Participants were assigned to riociguat or continued PDE-5 inhibitor therapy. In the riociguat arm, PDE-5 inhibitor treatment was stopped, followed by a defined washout period and initiation of riociguat. The starting dose was 1 mg riociguat TID, followed by an 8 weeks dose-adjustment phase according to the approved dose-adjustment scheme. The exact length of the washout period is not reported in the registry record. In the comparator arm, participants continued PDE-5 inhibitor therapy up to Week 24. Other standard-of-care treatment was at the investigator's discretion.
The open-label design means that treatment assignment was not masked. Participants and investigators could know which strategy was being followed. Randomization is intended to make the assigned groups comparable on average, but it does not remove the possibility that awareness of treatment influences care, reporting, or assessments. Such concerns can matter particularly for outcomes involving judgment or participant effort. The record does not report details of the randomization sequence or allocation concealment.
The primary endpoint was assessed at Week 24 in the Full Analysis Set with evaluable participants. The registry lists changes in 6 Minute Walking Distance, NT-proBNP, and WHO Functional Class, along with adjudicated clinical worsening, as secondary outcomes. The registry record does not report the planned allocation ratio, a sample-size justification, or detailed statistical analysis procedures.
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: 293 participants were screened in this study. Of these, 67 participants did not enter the treatment period (60 screening failures; 2 withdraw during screening; 2 withdraw following physician decision; 3 withdraw due to other reasons). 226 participants were randomized, of which 1 participant withdraw before treated.
Overall Study
| Stage | Riociguat | PDE-5i |
|---|---|---|
| STARTED | 111 | 114 |
| COMPLETED | 104 | 107 |
| NOT COMPLETED | 7 | 7 |
Reasons for not completing this period:
| Reason | Riociguat | PDE-5i |
|---|---|---|
| Adverse Event | 3 | 0 |
| Death | 0 | 4 |
| Physician Decision | 1 | 0 |
| Pregnancy | 1 | 0 |
| Withdrawal by Subject | 2 | 3 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS) with evaluable participants
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Riociguat | PDE-5i | Total |
|---|---|---|---|---|
| Participants analysed | 111 | 114 | 225 | |
| Age, Continuous | years | 49.4 (SD 16.16) | 49.2 (SD 15.64) | 49.3 (SD 15.86) |
| Sex: Female, Male: Female | Participants | 82 | 95 | 177 |
| Sex: Female, Male: Male | Participants | 29 | 19 | 48 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 32 | 31 | 63 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 75 | 80 | 155 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 4 | 3 | 7 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 17 | 19 | 36 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 | 5 | 9 |
| Race (NIH/OMB): White | Participants | 86 | 89 | 175 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 | 1 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Satisfactory Clinical Response at Week 24, measured over At Week 24.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with satisfactory clinical response at Week 24. The record defines response as meeting at least two of three criteria. The first is an increase in 6 Minute Walking Distance of at least 10% or at least 30 m from baseline to Week 24. The second is WHO Functional Class I or II at Week 24. The third is an NT-proBNP reduction of at least 30% from baseline to Week 24, expressed as a Week 24-to-baseline ratio no more than 0.7, and no defined clinical worsening.
A composite endpoint can capture response across more than one aspect of a condition. It may also classify participants with different response patterns together, because the criteria can be met in different combinations. Consequently, the overall responder count does not by itself reveal which component drove the classification. Component-level results are needed to understand how participants met or failed to meet the composite definition.
The endpoint is used to summarize whether participants reached a prespecified combination of clinical and biomarker targets by a fixed follow-up time. It is a count of participants, not a measure of the average change in walking distance or NT-proBNP. Although the registry specifies the endpoint and analysis population, it does not report the arm-specific responder counts or a comparative estimate. The observed size and precision of any treatment-group difference therefore cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record specifies the primary endpoint but does not report the number of participants with satisfactory clinical response in either group. It also does not report a treatment-group contrast, confidence interval, or primary-endpoint significance test. As a result, there is no posted primary result from which to describe the direction, magnitude, or precision of the comparison. The endpoint definition alone is not evidence that either strategy had a higher response rate.
The response measure is binary at the participant level: each evaluable participant either meets the composite definition or does not. The criteria permit different routes to a response classification. A participant may satisfy the walking-distance and functional-class criteria, for example, without meeting the biomarker criterion; the registry's definition does not require all three. Conversely, a single favorable component is insufficient. This makes the responder count a compact summary, but it can conceal differences in the component outcomes.
The record lists secondary outcomes, including changes from baseline in 6 Minute Walking Distance, NT-proBNP, and WHO Functional Class, as well as adjudicated clinical worsening at Week 24. Their presence indicates that the registry describes additional outcomes beyond the primary composite. However, their numerical results and the analysis details are not reported in the registry record. No conclusion about those secondary comparisons can be drawn from their names alone.
Safety information is reported separately. The registry records serious adverse events affecting 8 participants among 111 at risk in the riociguat group and 19 among 114 at risk in the PDE-5i group. Other adverse events affected 77 among 111 and 72 among 114, respectively. The recorded deaths were 0 in the riociguat group and 4 in the PDE-5i group. These are descriptive counts; the record does not provide a causal assessment or an adjusted comparison. They should not be treated as proof that a treatment caused or prevented an event.
The serious-event terms listed include Hypotension, Pneumonia, Pulmonary hypertension, and Pulmonary arterial hypertension, each reported as 1.8%, and Right ventricular failure and Small intestinal obstruction, each reported as 0.9%. These term-specific percentages do not supply a full account of event timing, severity, recurrence, or attribution. The registry record also does not report confidence intervals for the safety counts.
Overall, the available information supports a description of the design, endpoint, and selected safety counts, but not a quantitative interpretation of the primary treatment comparison. A careful reading distinguishes the planned question from the results actually reported. In particular, enrollment and completion status do not substitute for endpoint findings, and a listed endpoint should not be read as an observed benefit or lack of benefit.
9. Statistical Methods Explained
The registry describes a randomized parallel-group comparison. In general, randomization assigns participants to treatment strategies by chance, with the goal of reducing systematic differences between groups at the start of a study. It does not guarantee that every baseline characteristic will be identical, nor does it remove all sources of bias after assignment. The registry record does not report the randomization method, allocation concealment procedures, or baseline results, so those aspects cannot be evaluated from this information.
What does an open-label design imply?
Open-label means treatment assignment was not masked. Participants and study personnel could know whether the participant switched to riociguat or continued PDE-5 inhibitor therapy. In general, awareness of assignment can influence behavior, treatment decisions, adherence, reporting of symptoms, and outcome assessment. Random assignment can help balance initial differences, but it cannot by itself prevent these post-assignment influences. The registry record does not describe additional safeguards for outcome assessment.
How is the primary outcome constructed?
The primary outcome counts participants meeting a composite response definition at Week 24. The definition requires at least two of three criteria: a specified increase in walking distance, a specified functional-class status, and a specified NT-proBNP reduction in the absence of defined clinical worsening. A composite combines information from several measures under a single rule. This can make a broad response definition easier to interpret as a single endpoint, while making it important to inspect the components separately. A similar overall responder count could arise from different patterns across the three criteria.
The endpoint is binary for each evaluable participant, even though its criteria use both continuous changes and categorical status. For example, walking distance and NT-proBNP are assessed against thresholds rather than treated as the endpoint's direct group-level mean change. This thresholding can discard information about how far a participant's result lies from the cutoff. The record does not report component-level primary results or explain how missing component measurements affected the response classification.
What does a count comparison tell us?
For a binary endpoint, the observed count indicates how many participants met the definition in each group. A comparative analysis can express the difference between groups using an effect measure and quantify uncertainty around it. A confidence interval is a general statistical tool for showing a range of values compatible with the data and model at a stated confidence level; it helps convey precision, not the probability that a particular treatment effect is true. No primary-endpoint counts, effect estimate, or confidence interval are reported in the registry record, so none can be interpreted.
Counts also need a clear analysis population and denominator. The primary outcome is specified for the Full Analysis Set with evaluable participants. This wording identifies the population for the listed endpoint but does not explain the operational rules for inclusion, evaluability, or missing observations. Those rules can affect both the numerator and the denominator in a participant-level analysis. Further analysis-population details are not reported in the registry record.
Why can over-dispersion matter?
Over-dispersion is a general concern when a statistical model assumes that variability is lower than the variability actually present in the data. For count outcomes, unaccounted-for over-dispersion can make standard errors too small and uncertainty intervals too narrow. It is not possible to determine whether over-dispersion is relevant to the primary endpoint from the endpoint label alone: the primary outcome is a count of participants meeting a binary definition, and the model and diagnostics are not reported. No claim about an over-dispersion adjustment can therefore be made.
How should planning calculations be read?
Sample-size calculations based on an observed effect are planning illustrations, not observed power. The registry record describes an illustration using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. These assumptions describe a calculation framework rather than the trial's own design justification. The record does not report a sample-size justification for the trial, and a planning illustration cannot establish that the study was adequately powered for its actual primary analysis.
The phrase observed power is especially unhelpful as a retrospective substitute for an effect estimate and its uncertainty. A result's precision depends on the observed data and analysis, while a planning calculation depends on assumptions about a target effect and design. The registry record does not report primary endpoint results from which a recalculated comparison or planning illustration could be checked. No recalculated primary result is presented.
What can be concluded from the statistical record?
The design and endpoint rules are described, but the main outcome results and detailed statistical plan are not. The registry record does not report the primary analysis model, covariate adjustments, handling of missing data, confidence intervals, or multiplicity procedures. Without those details and the endpoint results, interpretation should remain limited to what the design intended to compare and the safety counts that are explicitly listed.
10. Multiplicity, Missing Data and Analysis Populations
The record lists a primary endpoint and secondary outcomes, including changes in walking distance, NT-proBNP, and WHO Functional Class, as well as adjudicated clinical worsening. It lists five outcome measures and five analyses. However, the record does not report how the analyses relate to one another, whether any testing hierarchy was used, or whether statistical significance was adjusted for multiple comparisons. A multiplicity procedure can help control the chance of false-positive findings when several hypotheses are tested; without a reported procedure, the treatment of multiple testing cannot be assessed.
The registry's skip note indicates that the primary outcome has several categories or time points and is not reduced to one comparison. Thus, a single primary contrast is not presented in the statistical record available for interpretation. The record does not give the category-specific results, time-point comparisons, or a prespecified hierarchy that would identify which contrast, if any, governs a primary conclusion.
The primary population is described as the Full Analysis Set with evaluable participants. The registry record does not report how missing outcome measurements were handled, how evaluability was defined, or whether sensitivity analyses were performed. The secondary outcomes for walking distance, NT-proBNP, and functional class specify last observation carried forward, including the stated Week 24 assessments. This identifies a missing-data approach for those listed outcomes, but the record does not provide the corresponding results or explain whether other approaches were assessed.
Last observation carried forward uses an earlier observed value in place of a later missing measurement. In general, this method can be misleading if the outcome would have changed after the last observation; its suitability depends on the data and assumptions. The registry record does not report the amount or pattern of missingness, so the impact of this approach cannot be evaluated. It also does not report an analysis plan that would resolve the unanswered questions about multiplicity, missing data, or analysis populations.
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 |
|---|---|---|---|
| Riociguat | 8 | 111 | 7.2% |
| PDE-5i | 19 | 114 | 16.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Riociguat | 0 of 111 |
| PDE-5i | 4 of 114 |
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 |
|---|---|
| Riociguat | 77 of 111 |
| PDE-5i | 72 of 114 |
Most frequent serious adverse event terms
| Event term | Organ system | Riociguat | PDE-5i |
|---|---|---|---|
| Pneumonia | Infections and infestations | 0 of 111 | 2 of 114 |
| Syncope | Nervous system disorders | 1 of 111 | 1 of 114 |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | 0 of 111 | 2 of 114 |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | 0 of 111 | 2 of 114 |
| Hypotension | Vascular disorders | 2 of 111 | 0 of 114 |
| Iron deficiency anaemia | Blood and lymphatic system disorders | 0 of 111 | 1 of 114 |
| Arrhythmia supraventricular | Cardiac disorders | 0 of 111 | 1 of 114 |
| Atrial fibrillation | Cardiac disorders | 0 of 111 | 1 of 114 |
| Cardiac failure | Cardiac disorders | 0 of 111 | 1 of 114 |
| Right ventricular failure | Cardiac disorders | 1 of 111 | 0 of 114 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Riociguat | PDE-5i |
|---|---|---|---|
| Headache | Nervous system disorders | 14 of 111 | 8 of 114 |
| Hypotension | Vascular disorders | 13 of 111 | 6 of 114 |
| Nasopharyngitis | Infections and infestations | 8 of 111 | 5 of 114 |
| Upper respiratory tract infection | Infections and infestations | 4 of 111 | 7 of 114 |
| Dyspepsia | Gastrointestinal disorders | 10 of 111 | 0 of 114 |
| Chest pain | General disorders | 5 of 111 | 5 of 114 |
| Diarrhoea | Gastrointestinal disorders | 6 of 111 | 3 of 114 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 8 of 111 | 1 of 114 |
| Nausea | Gastrointestinal disorders | 5 of 111 | 3 of 114 |
| Fatigue | General disorders | 6 of 111 | 2 of 114 |
Serious events with the highest arm-level rate: hypotension (1.8%), pneumonia (1.8%), pulmonary hypertension (1.8%), pulmonary arterial hypertension (1.8%), right ventricular failure (0.9%).
The registry reports serious adverse events and other adverse events separately. For serious adverse events, 8 participants among 111 at risk are listed in the riociguat group, compared with 19 among 114 at risk in the PDE-5i group. For other adverse events, the corresponding reported counts are 77 among 111 and 72 among 114. Recorded deaths are 0 in the riociguat group and 4 in the PDE-5i group.
These counts describe participants with reported events, not the number of all event episodes. The groups' risk counts provide the stated denominators for the adverse-event summaries, but the registry record does not report event timing, duration, recurrence, exposure-adjusted rates, or a statistical comparison. The counts alone do not establish that treatment assignment caused an event or that an event was prevented.
The record lists Hypotension, Pneumonia, Pulmonary hypertension, and Pulmonary arterial hypertension at 1.8% each among the top serious-event terms; Right ventricular failure and Small intestinal obstruction are listed at 0.9% each. These percentages are reported as given. The record does not provide further detail about the denominator or attribution for each term, so they should not be interpreted as comparative treatment effects. Safety findings need to be read alongside the clinical context and the completeness of adverse-event reporting, neither of which can be fully assessed from these figures alone.
12. What the Result Does, and Does Not, Mean
The registry record establishes what comparison the study set out to make: switching from PDE-5 inhibitor therapy to riociguat versus continuing PDE-5 inhibitor therapy in patients with pulmonary arterial hypertension who were not at treatment goal. It also describes the primary response definition and provides selected safety counts. These are useful for understanding the design and the intended interpretation of the endpoint.
The record does not, however, report the primary endpoint counts or a comparative treatment estimate. It therefore cannot show whether more participants met the composite response definition in either group, how large any difference was, or how precise the estimate might be. The same limitation applies to the listed secondary outcomes because their numerical results are not reported in the registry record. Completion of the study and its enrollment figure do not answer the outcome question.
The composite response definition also should not be treated as interchangeable with any one component. The overall responder classification combines walking distance, functional class, and NT-proBNP under a rule that requires at least two criteria. Without component results, the response pattern cannot be described. Nor can the endpoint alone show the effect on every clinically relevant aspect of pulmonary arterial hypertension.
The safety counts are descriptive and should be distinguished from evidence of causation. The counts do not account in the information reported for differences in follow-up exposure, event timing, or other factors that may matter to safety comparisons. The record does not provide an inferential safety analysis. Neither the observed counts nor the absence of a reported primary result should be interpreted as proof of safety or lack of safety.
In general, a treatment comparison is best interpreted using its estimate, uncertainty interval, analysis population, outcome definitions, and missing-data procedures together. Here, several of those elements are not reported in the registry record. The defensible conclusion is consequently limited: the study was randomized and open-label, its primary endpoint was a Week 24 composite response, and the posted primary results are insufficient to characterize the comparative response.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of a treatment-switch question rather than a comparison of starting a treatment against no treatment. The intervention strategy involved stopping an existing PDE-5 inhibitor, a defined washout period, and riociguat initiation with dose adjustment. The comparator continued PDE-5 inhibitor treatment, with other standard-of-care care left to investigator discretion. Interpretation therefore concerns these strategies as described, not an isolated drug effect under otherwise identical treatment conditions.
The primary outcome illustrates a common trade-off in composite endpoints. Combining walking distance, functional class, and a biomarker creates a single response classification that can represent more than one dimension of clinical status. At the same time, the composite can obscure which component contributes to a group difference and whether components move in the same direction. Component-level findings are important for interpreting what the composite means in practice, but they are not reported in the registry record.
The open-label design also makes the distinction between randomized assignment and masked assessment relevant. Randomization can reduce baseline confounding on average, but awareness of treatment may affect some outcomes or care decisions. Understanding how the study addressed this concern requires details that are not reported in the registry record.
Finally, the record demonstrates why a completed trial and a defined primary endpoint are not enough for statistical interpretation. Without arm-specific endpoint results, an effect estimate, and a measure of uncertainty, the central comparison cannot be evaluated. The registry's safety counts add descriptive information but do not replace the missing efficacy results or a formal safety analysis. Clear reporting of results, missing-data handling, and multiplicity procedures is necessary to connect a trial's design to a well-calibrated conclusion.
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 it does not report the primary endpoint results. Arm-specific responder counts, a comparative estimate, and its uncertainty are not available. The secondary outcomes are listed, but their numerical results are also not reported in the registry record. This prevents assessment of the direction, magnitude, or precision of the central comparison and its supporting outcomes.
The statistical analysis is not described in enough detail to evaluate how the primary comparison was conducted. The record does not report the model, covariate adjustment, detailed analysis population rules, or handling of missing primary-endpoint data. It names the Full Analysis Set with evaluable participants but does not define evaluability. It also does not report a multiplicity procedure despite listing multiple outcomes and analyses.
The composite endpoint can conceal variation among its components. The record does not report how many participants met each criterion or which combinations contributed to the response classification. The open-label design may also permit awareness of assignment to influence care or assessment; the record does not describe masking of outcome assessors or other safeguards.
For safety, the posted information includes participant counts and selected serious-event terms, but not a detailed comparative analysis, event timing, exposure duration, or attribution. The listed counts should therefore be treated as descriptive. The record does not report a sample-size justification, so it is not possible to judge the intended precision or statistical power from the design description alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy — NCT02891850.
- Registry record last updated 2021-02-26; status last verified 2021-01.
- Results first posted 2021-01-22.
- 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
NCT02891850 is a completed, randomized, Phase 4, parallel-group, open-label study of riociguat replacing PDE-5 inhibitor therapy versus continued PDE-5 inhibitor therapy in pulmonary arterial hypertension. Enrollment was 225. The record describes patients on stable PDE-5 inhibitor treatment, with or without an endothelin receptor antagonist, who were not at treatment goal.
The primary endpoint was the number of participants with satisfactory clinical response at Week 24, defined by meeting at least two of three criteria involving walking distance, functional class, and NT-proBNP. The registry record does not report the primary endpoint results or a between-group estimate. It lists secondary outcomes for functional measures and adjudicated clinical worsening, but their numerical results are not reported in the registry record.
Reported safety counts include serious adverse events affecting 8 participants among 111 at risk in the riociguat group and 19 among 114 in the PDE-5i group. These are descriptive figures and do not establish causation. The principal limitation for interpretation is the absence of the primary and secondary outcome results and detailed analysis procedures.